• Subjects with chronic kidney disease (estimated glomerular filtration rate < 60).
• Recruitment will primarily focus on patients with end stage renal disease who are being considered for renal transplantation or initiation of hemodialysis.
• Minorities will be included.

• Individuals < 18 years of age.
• Subjects not diagnosed with chronic kidney disease.

Eligibility last updated 8/18/21. Questions regarding updates should be directed to the study team contact.

• Patients must understand and provide written informed consent prior to initiation of any study-specific procedures.
• ≥ 18 years of age.
• Patients must have a diagnosis of confirmed malignancy.
• Patient is a good medical candidate for a standard of care or research biopsy or surgical procedure to obtain tissue or has tissue available for analysis that has been collected within 12 months of signing consent.

• Uncontrolled concurrent illness including psychiatric illness, or situations that would limit compliance with the study requirements or the ability to willingly give written informed consent.
• Inaccessible tumor for biopsy or patient does not have tumor tissue available for research use.
• Biopsy must not be considered to be more than minimal risk to the patient.
• Contraindications to percutaneous biopsy:
  • Significant coagulopathy that cannot be adequately corrected;
  • Severely compromised cardiopulmonary function or hemodynamic instability;
  • Lack of a safe pathway to the lesion;
  • Inability of the patient to cooperate with, or to be positioned for, the procedure.

Eligibility last updated 11/10/21. Questions regarding updates should be directed to the study team contact.

• Capable and willing to provide informed consent.
• Confirmed or suspected physician diagnosis of Primary Immunodeficiency.

• Not willing to provide consent.
• Not diagnosed with Primary Immunodeficiency.

Eligibility last updated 9/10/21. Questions regarding updates should be directed to the study team contact.

​​​​​

• Male or female subjects aged 18 or older at the time of signed informed consent.
• In the opinion of the Investigator, there is no other meaningful life-prolonging therapy option available.
• Population:
  • Part 1: Must have documented diagnosis of ovarian cancer, endometrial cancer, colorectal cancer, gastric cancer, gastroesophageal junction cancer, triple negative breast cancer, non-small cell lung cancer, or cholangiocarcinoma.
  • Part 2 Stage 1: Must have one of the following cancer types indicated below with the corresponding expression level of FRα.:
  • Ovarian Cancer
    • Moderate and/or High
  • Endometrial Cancer
    • Moderate and/or High
  • Colorectal Cancer
    • Moderate and/or High
  • Gastric Cancer
    • Moderate and/or High
  • Gastroesophageal Junction Cancer
    • Moderate and/or High
  • Triple Negative Breast Cancer
    • Moderate and/or High
  • Non-small cell lung cancer
    • Moderate and/or High
  • Cholangiocarcinoma
    • Moderate and/or High
  • Specific cancer types from the table above will be selected by the Sponsor, in consultation with the Part 1 CSRC and other experts, at the conclusion of Part 1 Dose Escalation. In addition, moderate and high FRα expression thresholds will be defined and communicated by the Sponsor to Investigators upon completion of translational testing prior to the start of Part 2.

Part 2 Stage 2 or Registration Study:

• Must have documented FRα expression in one of the topoisomerase 1 inhibitor-sensitive tumor types evaluated in Part 2 Stage 1. Specific tumor groups will be selected by the Sponsor, in consultation with the CSRC and/or Steering Committee (SC) and other experts, at the conclusion of Part 2 Stage 1.
• Folate receptor α (FRα) expression:
  • Part 1: Must provide archival tumor tissue or a newly obtained tumor biopsy specimen prior to the first dose of study drug for retrospective FRα expression analysis. The availability of the FRα expression result is not required to start study drug administration.
  • Part 2: Must provide archival tissue or a newly obtained tumor biopsy specimen prior to the first dose of study drug for prospective determination of FRα overexpression at the Sponsor-designated laboratory. The FRα expression result is required prior to the initiation of study drug administration.
• In Part 1, measurable disease or, in the absence of measurable disease, non-measurable disease (lesions considered truly non-measurable include leptomeningeal disease, ascites, pleural or pericardial effusion, inflammatory breast disease, lymphangitic involvement of skin or lung, abdominal masses/abdominal organomegaly identified by physical exam that is not measurable by reproducible imaging techniques), as per RECIST v1.1. In Part 2, measurable disease (only), as per RECIST v1.1.
  • Note:  A lytic or mixed lytic-blastic bone lesion with a soft tissue component assessed on CT/MRI can be measurable if the minimum size criteria are met.
• For other criteria, refer to RECIST v1.1.
• Expected survival of at least 3 months.
• In Part 1, Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 or 2.
• In Part 2, ECOG Performance Status of 0 or 1.
• Adequate organ function defined as:
  • Absolute neutrophil count ≥ 1,500/μL;
  • Platelets ≥ 100,000/μL;
  • Hemoglobin ≥ 8 g/dL;
  • Total bilirubin ≤ 1.5 x upper limit of normal (ULN) (including subjects with documented Gilberts syndrome, liver metastases, or other etiologies);
  • Aspartate transaminase (AST)/alanine transaminase (ALT) ≤ 5 x ULN;
  • Calculated creatinine clearance ≥ 60 mL/min using the Cockcroft-Gault equation.
• Recovered from any previous surgery and no history of major surgery within the last 28 days prior to start of study drug.
• For women of childbearing potential, willingness to avoid pregnancy by using an effective method of contraception from the first dose of ELU001 up to 5 times the half-life of ELU001 treatment (about 10 days) plus 6 months after the last dose of study drug (or longer, if required by Regulatory Authority or local practice).
• For males who are capable of fathering a child, willingness to take precautions that are effective in preventing pregnancy from the first dose of ELU001 and up to 5 times the half-life of ELU001 treatment (about 10 days) plus 3 months after the last dose of study drug (or longer, if required by Regulatory Authority or local practice).
• Willing and able to understand and comply with all aspects of the protocol.
• Provided informed consent prior to any protocol-related procedures, including screening evaluations.

• Clinically significant active or chronic corneal disorder.
• Received investigational anti-cancer treatment, other anti-neoplastic therapy, including cytotoxics, targeted agents, biological therapy including antibodies and endocrine therapies ≤ 4 weeks, or within a time interval less than at least 5 half-lives of the investigational agent, prior to starting study drug, whichever is shorter.
• Require use of folate-containing supplements during the treatment period.
• Known medical history of:
  • Clinically significant cardiovascular and respiratory conditions including myocardial infarction within 1 year, uncontrolled or unstable angina, congestive heart failure (New York Heart Association [NYHA] Class III or IV), or arrhythmia (Grade 2 or higher), within 5 years;
  • Another malignancy within 3 years before the first dose, or previously diagnosed with another malignancy, and have any evidence of residual disease. Subjects with non-melanoma skin cancer or cervix carcinoma in situ, treated and radiated early prostate cancer if they have undergone complete resection, or chronic lymphocytic leukemia (CLL) who is on close monitoring and treatment is not required, are not excluded;
  • Grade 3 or 4 anemia, neutropenia or thrombocytopenia due to prior chemotherapy that persisted > 4 weeks and was related to the most recent treatment;
  • Serious, uncontrolled medical disorder such as seizures, nonmalignant systemic disease, or active, uncontrolled infection or active infection causing fever. Examples include, but are not limited to, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, or any psychiatric disorder that prohibits obtaining informed consent. Subjects with chronic diseases that are well controlled (e.g., diabetes mellitus, hypertension (< 150 systolic blood pressure [sBP] and < 90 diastolic blood pressure [BP]) are eligible;
  • Part 1 only: Recognized immunodeficiency condition including cellular immunodeficiencies, hypogammaglobulinemia or dysgammaglobulinemia; subjects who have hereditary, or congenital immunodeficiency’s (human immunodeficiency virus (HIV) infection, see below).
• Any of the following conditions (testing is not required in this protocol, unless required by Regulatory Authority or local practice)
  • Known HIV-infected subjects, unless on effective anti-retroviral therapy with an undetectable viral load within 6 months; or
  • Known or suspected hepatitis B if active infection (subjects with chronic hepatitis B infection must have an undetectable Hepatitis B Virus (HBV) viral load on suppressive therapy, if indicated; positive surface antibody alone is not an exclusion); or
  • Known or suspected hepatitis C infection which has not been treated and cured unless currently on treatment with an undetectable viral load.
• Active medical conditions of:
  • Subjects in Part 1 with autoimmune disease (e.g., rheumatoid arthritis, Systemic Lupus Erythematosus (SLE), ulcerative colitis, Crohn's Disease, Multiple Sclerosis (MS), ankylosing spondylitis, thyroiditis) requiring continuing immune suppressive therapy;
  • Subjects in Part 1 with brain or leptomeningeal metastases; in Part 2, subjects with symptomatic brain or leptomeningeal metastases with any lesion greater than 3 cm, or evidence of herniation or hemorrhage.
• Any of the following recent treatments or therapies:
  • Subject has received a transfusion (platelets or red blood cells) ≤ 2 weeks prior to first dose of study drug;
  • Chronic therapeutic corticosteroid use, defined as > 5 days of prednisone or equivalent in Part 1, except for inhalers or those on a pre-planned steroid taper.
  • Note: Premedication with corticosteroids to prevent or decrease the severity of infusion related reactions per institutional standard of care is allowed;
  • Chronically treated with systemic doses of other immunosuppressive drugs such as cyclosporine, methotrexate, adrenocorticotropic hormone (ACTH) or immune suppressive monoclonal antibodies.
• Female subjects who are lactating or breast feeding or have a positive pregnancy test within 7 days prior to first dose of study drug.
• Any condition(s) that, in the opinion of the Investigator, would increase the risk for toxicities from study drug, interfere with subject compliance or conduct of this study.
• In the opinion of the Investigator, there is significant risk to a subject when the tumor tissue biopsy specimen procedure is performed
• Subjects who have a QTcF > 470 ms within 4 weeks prior to the first dose of study drug.

Eligibility last updated 10/26/22. Questions regarding updates should be directed to the study team contact.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 8/24/22. Questions regarding updates should be directed to the study team contact.

Inclusion Criteria

• Willing and able to provide written informed consent. If the subject is unable to consent for himself/herself, a legally authorized representative must provide informed consent on his/her behalf.
• Males or females ≥ 18 years of age.
• Evidence of candidemia or invasive candidiasis based on growth of Candida species from any of the following: blood, peritoneal fluid, intra-abdominal collection/abscess, pancreatic fluid/tissue, peripancreatic fluid, pleural fluid/tissue.

• Severe neutropenia (absolute neutrophil count < 500 cells/microL).
• Profound lymphopenia (< 300 cells/microL).
• The Principal Investigator (PI) is of the opinion that the subject should not participate in the study.

Eligibility last updated 8/23/21. Questions regarding updates should be directed to the study team contact.

• Diagnosis of imperforate anus.

• Lack of a parent or guardian to provide informed consent.

Eligibility last updated 9/24/21. Questions regarding updates should be directed to the study team contact.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 12/16/22. Questions regarding updates should be directed to the study team contact.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 5/18/23. Questions regarding updates should be directed to the study team contact.

• Adult female patients 18 to 99 years of age.
• Patients with proven breast cancer and nodal metastases referred for staging breast MR within the Department of Radiology.
• Patients who are able and willing to sign the informed consent.
• Negative pregnancy test if subject is of child-bearing age (females of child-bearing potential will be screened for pregnancy using a urine pregnancy test, which will be administered by the unit study coordinator at no cost to the patient).

• Minors under 18 years of age.
• Patients unable to provide written informed consent.
• Pregnancy.
• eGFR ≤ 30 (4,5).
• History of prior moderate or severe contrast reaction including unresponsiveness, severe respiratory distress, convulsions, arrhythmia, cardiopulmonary distress, progressive angioedema, laryngeal edema, dyspnea, bronchospasm, symptomatic tachycardia, symptomatic bradycardia, hypotension, hypertensive crisis.
• Any history of premedication prior to iodinated contrast.
• Patients that consent to participation but do not undergo their clinically indicated MR scanning for any reason (e.g., bad IV, infiltration, reaction, change in indication).

Eligibility last updated 8/24/21. Questions regarding updates should be directed to the study team contact.

• 18 years of age and older.
• Patient is a good medical candidate for a standard of care or research biopsy or surgical procedure to obtain tissue.

• Individuals < 18 years of age.
• Uncontrolled concurrent illness including psychiatric illness, or situations that would limit compliance with the study requirements or the ability to willingly give written informed consent.
• Inaccessible tumor for biopsy or patient does not have tumor tissue available for research use.
• Biopsy must not be considered to be more than minimal risk to the patient.
• Have a contraindication to percutaneous biopsy including:
  • Significant coagulopathy that cannot be adequately corrected;
  • Severely compromised cardiopulmonary function or hemodynamic instability;
  • Lack of a safe pathway to the lesion per the interventional radiologist;
  • Inability of the patient to cooperate with, or to be positioned for, the procedure.

Eligibility last updated 8/23/21. Questions regarding updates should be directed to the study team contact.

• Individuals ≥ 18 years of age.
• Adult kidney transplant recipients awaiting transplant, kidney transplant recipients and living kidney donors.

• Subjects under 18 years of age.

Eligibility last updated 9/28/21. Questions regarding updates should be directed to the study team contact.

• Patient presenting to a General Internal Medicine Service.
• Patient in one of the 3 Mayo Clinic Campuses (Rochester, Arizona, Florida).
• Patient with an undiagnosed mass: New or enlarging lymph nodes clinically or on imaging:
  • New mass on imaging of soft tissues, bone, spleen, adrenal gland, retroperitoneum, or intraabdominal location without clear organ association .
• Patient has understood and signed the informed consent to participate in the registry.
• Patient has the ability to complete all aspects of registry enrollment.
• Aged 18 and older.

• Mass involving the breast, brain, kidney, lung, ovary/adnexa, liver, pancreas, sinus, throat, or thyroid gland will be addressed by the respective specialty areas.  
• Patients with a known history of any condition or factor judged by the investigator to preclude participation in the registry or which might hinder adherence.
• Lacking the capacity to consent.
• Prisoners or institutionalized individuals.
• Pregnant women.

Eligibility last updated 9/17/21. Questions regarding updates should be directed to the study team contact.

Eligibility last updated6/7/22. Questions regarding updates should be directed to the study team contact.

Inclusion Criteria
•Study Arm 1 Preschool Children < 6 years old Asthma Group (N=200) :

• Diagnosis of asthma.
• In the absence of an asthma diagnosis:
  • Persistent wheezing of at least one year;
  • Even distribution of socio-demographics including age, gender, race and ethnicity.

• Actively sick with covid or flu.

Inclusion Criteria
•Non-Asthma/Disease Controls (N=200) :

• Diagnosis of allergy.
• Even distribution of sociodemographics including age, gender, race and ethnicity.

• Diagnosis of asthma.
• Recurrent wheezing.
• Actively sick with covid or flu.

Inclusion Criteria
•Healthy Controls (N=200) : 

• Not having or suspected of having any known upper/lower respiratory disease.
• Even distribution of sociodemographics including age, gender, race and ethnicity.

• Diagnosis of asthma or any known upper/lower respiratory disease.
• Diagnosis of allergy.
• Actively sick with covid or flu.

Inclusion Criteria
•Study Arm 2 Children 6-17 years of age Asthma Group (N=200) :

• Diagnosis of asthma.
• In the absence of an asthma diagnosis:
  • Persistent wheezing of at least one year.
• Even distribution of sociodemographics including age, gender, race and ethnicity.

• Actively sick with covid or flu.  

Inclusion Criteria
•Non-Asthma/Disease Controls  (N=200) :

• Diagnosis of allergy. 
• Even distribution of sociodemographics including age, gender, race and ethnicity.

• Diagnosis of asthma.
• Recurrent wheezing.
• Actively sick with covid or flu.

Inclusion Criteria
•Healthy Controls  (N=200) :

•  Not having or suspected of having any known upper/lower respiratory disease.
• Even distribution of sociodemographics including age, gender, race and ethnicity. 

• Diagnosis of asthma or recurrent wheezing.
• Diagnosis of allergy.
• Actively sick with covid or flu.

Inclusion Criteria
•Study Arm 3  Adults > 18 years old
Asthma Group (N=200) :

• Diagnosis of asthma.
• Even distribution of sociodemographics including age, gender, race and ethnicity. 

• Actively sick with covid or flu.  

Inclusion Criteria
•Non-Asthma/Disease Controls (N=200) :

• Diagnosis of allergy.
• Even distribution of sociodemographics including age, gender, race and ethnicity. 

• Diagnosis of asthma.
• Recurrent wheezing.
• Actively sick with covid or flu.

Inclusion Criteria
•Healthy Controls  (N=200) :

•  Not having or suspected of having any known upper/lower respiratory disease.
• Even distribution of socio-demographics including age, gender, race and ethnicity.

Exclusion Criteriao: 

• Diagnosis of asthma.
• Diagnosis of allergy.
• Actively sick with covid or flu.

Eligibility last updated 11/2/22. Questions regarding updates should be directed to the study team contact.

• Patient has provided informed consent
• Patient is willing and able to comply with clinic visits and procedures outlined in the study protocol
• Male or female, at least 18 years of age
• Patients must have an ECOG performance status of 0 or 1.
• Laboratory measurements, blood counts:
  • Hemoglobin must be ≥ 9 g/dL prior to initial dose of study treatment. Red blood cell
    (RBC) transfusions are allowed to meet hemoglobin eligibility within limits set per
    Exclusion Criterion #4 
  • Absolute neutrophil count (ANC) at least 1.5 x 10^9/L without growth factor support
    within 2 weeks of study treatment initiation
  • Platelets at least 100 x 10^9/L
• Laboratory measurements, renal function:
  • Patients must have adequate renal function as demonstrated by a creatinine clearance of at least 30 mL/min; calculated by the Cockcroft Gault formula
• Adequate liver function, as demonstrated by:
  • AST less than or equal to 2.5 x ULN or less than or equal to 5 x ULN in patients with liver metastases
  • ALT less than or equal to 2.5 x ULN or less than or equal to 5 x ULN in patients with liver metastases
  • Bilirubin less than or equal to 1.5 x ULN, or less than or equal to 3.0 x ULN and primarily unconjugated if patient has a documented history of Gilbert’s syndrome or genetic equivalent
• Pretreatment blood cross-match completed (Section 7.8.1.1)
• Male and female patients of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception as described in Appendix 5.
• Measurable disease according to response evaluation criteria in solid tumors (RECIST),Version 1.1. Previously irradiated lesions can be considered as measurable disease only if disease progression has been unequivocally documented at that site since radiation.
• Patients must have a life expectancy of 3 months or greater, in the opinion of the investigator.

Safety Run-in Cohort 1 and Phase 2 Cohort 1
In addition to meeting the inclusion criteria for all patients, patients who are enrolled into Safety
Run-in Cohort 1 and Phase 2 Cohort 1 must fulfill the following cohort-specific inclusion
criteria:

• Patients previously untreated for unresectable locally advanced or mTNBC that is histologically or cytologically confirmed based on the most recent analyzed biopsy or other pathology specimen, defined as negative for estrogen receptor (ER), progesterone receptor (PR), and Human Epidermal Growth Factor Receptor 2 (HER2) according to the most recent American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guideline (Appendix 9).
• Patients whose tumors are considered PD-L1 negative, as determined by an approved test according to local standards.
• Prior systemic treatment for neoadjuvant and/or adjuvant therapy and/or curative intent radiation therapy is permitted if completed at least 6 months prior to enrollment.

Note: Maintenance therapies are not counted as separate lines of therapy.

Safety Run-in Cohort 2 and Phase 2 Cohort 2
In addition to meeting the inclusion criteria for all patients, patients who are enrolled into Safety
Run-in Cohort 2 and Phase 2 Cohort 2 must fulfill the following cohort-specific inclusion
criterion:

• Patients with unresectable, locally advanced or mTNBC that is histologically or cytologically confirmed based on the most recent analyzed biopsy or other pathology specimen, defined as negative for ER, PR, and HER2 according to the most recent ASCO/CAP guideline (Appendix 9), who have received 1 prior line of therapy in the unresectable, locally advanced/metastatic setting. Patients must have been previously treated with a taxane in the neoadjuvant, adjuvant, or locally advanced/metastatic setting
• Patients with tumors considered positive for PD-L1 expression (as determined by an approved test according to local standards) must have received an immune checkpoint inhibitor for 1L treatment of locally advanced/metastatic disease

• Positive serum pregnancy test.
• Breastfeeding female.
• Active central nervous system (CNS) disease. Patients with asymptomatic and stable, treated CNS lesions (radiation and/or surgery and/or other CNS-directed therapy who have not received corticosteroids for at least 4 weeks) are allowed.
• Red blood cell (RBC) transfusion dependence, defined as requiring more than 2 units of packed RBC transfusions during the 4-week period prior to screening. RBC transfusions are permitted during the screening period and prior to enrollment to meet the hemoglobin inclusion criteria.
• History of hemolytic anemia, autoimmune thrombocytopenia, or Evans syndrome in the last 3 months.
• Known hypersensitivity to any of the study drugs, the metabolites, or formulation excipient.
• Prior treatment with cluster of differentiation 47 (CD47) or signal regulatory protein alpha-targeting agents.
• Current participation in another interventional clinical trial.
• Known inherited or acquired bleeding disorders.
• Significant disease or medical conditions, as assessed by the investigator and sponsor, that would substantially increase the risk-benefit ratio of participating in the study. This includes, but is not limited to, acute myocardial infarction within the last 6 months, unstable angina, uncontrolled diabetes mellitus, significant active infections, and congestive heart failure New York Heart Association Class III-IV
• Second malignancy, except treated basal cell or localized squamous skin carcinomas, localized prostate cancer, or other malignancies for which patients are not on active anticancer therapies and who are in complete remission for over 2 years.
• Known active or chronic hepatitis B or C infection or human immunodeficiency virus infection in medical history).
• Prior anticancer therapy including but not limited to chemotherapy, immunotherapy, or investigational agents within 4 weeks prior to magrolimab is not permitted.
• Uncontrolled pleural effusion.
• Uncontrolled hypercalcemia (ionized calcium >1.5 mmol/L) or symptomatic hypercalcemia requiring continued use of bisphosphonate therapy.
• Uncontrolled tumor-related pain.
• Severe/serious systemic infection within 4 weeks of randomization.
• Rapid deterioration during screening prior to enrollment (eg, significant change in performance status, 20% or greater decrease in serum albumin levels or uncontrolled tumorrelated pain)
• Other concurrent medical or psychiatric conditions that, in the investigator’s opinion, may be likely to confound study interpretation or prevent completion of study procedures and followup
  examinations
• Prior anticancer therapy including but not limited to chemotherapy, immunotherapy, or investigational agents within 4 weeks prior to magrolimab is not permitted
• Patients who have received a live vaccine within 30 days of randomization
   

Safety Run-in Cohort 1 and Phase 2 Cohort 1
Patients who meet the following exclusion criterion are not eligible to be enrolled into Safety
Run-in Cohort 1 or Phase 2 Cohort 1:

• Disease progression within 6 months following neoadjuvant/adjuvant therapy or rapid visceral progression and/or symptomatic disease, where single-agent chemotherapy would not be appropriate.

NOTE: Localized non-CNS radiotherapy, previous hormonal therapy with luteinizing hormonereleasing
hormone agonists for breast cancer, and treatment with bisphosphonates and receptor
activator of nuclear factor kappa B ligand inhibitors are not criteria for exclusion. There is no
required minimum washout period for these therapies. Patients should be recovered from the
effects of radiation.

Safety Run-in Cohort 2 and Phase 2 Cohort 2
Patients who meet any of the following exclusion criteria are not eligible to be enrolled into
Safety Run-in Cohort 2 or Phase 2 Cohort 2:

• Patients with active chronic inflammatory bowel disease (ulcerative colitis, Crohn disease) and patients with a history of bowel obstruction or gastrointestinal perforation within 6 months of enrollment
• Patients who previously received topoisomerase I inhibitors or antibody-drug conjugates containing a topoisomerase inhibitor
• High-dose systemic corticosteroids (≥ 20 mg of prednisone or its equivalent) are not allowed within 2 weeks of Cycle 1 Day 1
• Have not recovered (ie, ≥ Grade 2 is considered not recovered) from AEs due to a previously administered agent
  • Note: patients with any grade neuropathy or alopecia are an exception to this criterion and will qualify for the study
  • Note: if patients received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy

NOTE: Localized non-CNS radiotherapy, previous hormonal therapy with luteinizing hormonereleasing hormone agonists for breast cancer, and treatment with bisphosphonates and receptor activator of nuclear factor kappa B ligand inhibitors are not criteria for exclusion. There is no required minimum washout period for these therapies. Patients should be recovered from the effects of radiation.

Eligibility last updated 2/18/22. Questions regarding updates should be directed to the study team contact.

• Age ≥ 18 years.
• Progressive or recurrent WHO Grade IV IDH wildtype glioblastoma (including molecular glioblastoma and gliosarcoma).
• Have an enhancing mass on MRI amenable to resection or biopsy of the tumor (as determined by the neurosurgeon pre-operatively) and histological diagnosis of glioblastoma from a prior biopsy or surgery.
• Willing to undergo resection or biopsy of their glioblastoma at Mayo Clinic in Rochester, MN.
• ECOG Performance Status (PS) of 0 or 1 and KPS ≥ 70.
  • Note: PS must be assessed again within 7 days prior to first dose of study drug.
• The following laboratory values obtained ≤ 15 days prior to registration:
  • Absolute neutrophil count (ANC) ≥ 1500/mm^3;
  • Platelet count ≥ 100,000/mm^3;
  • Hemoglobin ≥ 9.0 g/dL without transfusion or EPO dependency (≤ 7 days prior to assessment);
  • Creatinine ≤ 2.0 x ULN OR measured or calculated creatinine clearance (per institutional standard) must be ≥ 45 ml/min;
  • Total bilirubin ≤ 1.5 x ULN OR Direct bilirubin ≤ULN for patients with total bilirubin levels > 1.5 x ULN;
  • Aspartate transaminase (AST) AND alanine transaminase (ALT) ≤ 2.5 x ULN;
  • INR/PT/aPTT ≤ 1.5 × ULN OR if patient is receiving anticoagulant therapy then INR or aPTT is within target range of therapy.
• Negative pregnancy test done ≤ 7 days prior to registration, for persons of childbearing potential only (POCBP).
  • Note: If testing done for eligibility is > 72 hours prior to first dose, then pregnancy testing must be repeated, and result must be negative for patient to receive treatment.
• POCBP or able to father a child must be willing to use adequate contraception starting with first dose through 120 days after last dose. 
• Provide written informed consent.
• Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study).
• Willing to provide tissue and blood samples for correlative research purposes.

Any of the following because this study involves an investigational agent whose genotoxic, mutagenic, and teratogenic effects on the developing fetus and newborn are unknown:

• Pregnant persons.
• Nursing persons.
• Persons of childbearing potential or able to father a child who are unwilling to employ adequate contraception.
• Signs or symptoms of life-threatening raised intracranial pressure: as defined by the treating neurosurgeon, including severe headache, nausea, decreasing level of consciousness, precluding 4-7 day delay in scheduling neurosurgery.
• Prior treatment.
• Received bevacizumab (AVASTIN) ≤ 28 days prior to registration.
  Note: Bevacizumab is allowed for symptom control during the adjuvant phase if the study.
• Received a live vaccine ≤ 30 days prior to registration.
• Major surgery ≤ 28 days prior to registration.
• Requirement for dexamethasone dose of > 2mg/day ≤ 2 days prior to registration.
• Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens.
• Immunocompromised patients and patients known to be HIV positive and currently receiving antiretroviral therapy.
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm.
• Other active malignancy requiring systemic treatment ≤ 1 year prior to registration.
• History of myocardial infarction ≤6 months prior to registration, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias.
• Active autoimmune disease that has required systemic treatment (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs) ≤ 2 years prior to registration.
  • Note: Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
• Known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected).
• Known history of active TB (Bacillus Tuberculosis).
• History of (non-infectious) pneumonitis that required steroids or current pneumonitis.
• Hypersensitivity to pembrolizumab or any of its excipients.
• Received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 5/16/23. Questions regarding updates should be directed to the study team contact.

Key

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 9/19/22. Questions regarding updates should be directed to the study team contact.

Key Eligibility Criteria (additional criteria may apply) Part 1 Key Inclusion Criteria

1. Pathologically confirmed solid tumors, e.g., Colorectal Cancer (CRC), Non-Small Cell
Lung Cancer (NSCLC), or Pancreatic Cancer (PANC), that is metastatic, unresectable locally
advanced, or in the Investigator's opinion the subject is high risk for incurable relapse
within two years.

Part 1: Key Exclusion Criteria

1. History of any of other malignancy in the past 5 years other than non-melanoma skin
carcinoma, low grade localized prostate cancer, superficial bladder cancer, ductal
carcinoma in situ (CIS) of the breast, CIS of the Cervix, or Stage I uterine cancer.

2. Prior allogeneic stem cell transplant.

3. Prior solid organ transplant.

Part 2 : Key Inclusion Criteria

1. Pathologically confirmed solid tumors, e.g., Colorectal Cancer (CRC), Non-Small Cell
Lung Cancer (NSCLC), Pancreatic Cancer (PANC), Mesothelioma, or Ovarian Cancer (OVAC)
that is metastatic, unresectable locally advanced, or in the Investigator's opinion
the subject is high risk for incurable relapse within two years.

2. Participants are germline HLA-A*02 heterozygous confirmed by HLA typing.

3. Primary tumor tissue showing LOH of HLA-A*02 by NGS testing.

4. Eastern Cooperative Oncology Group (ECOG) 0 or 1 performance status.

Part 2: Key Exclusion Criteria

1. History of any of other malignancy in the past 5 years other than non-melanoma skin
carcinoma, low grade localized prostate cancer, superficial bladder cancer, ductal
carcinoma in situ (CIS) of the breast, CIS of the Cervix, or Stage I uterine cancer.

2. Prior allogeneic stem cell transplant.

3. Prior solid organ transplant.

4. Participants who have received any cancer therapy on any investigational therapy for
any indication, including but not limited to chemotherapy, small molecules, monoclonal
antibodies, or radiotherapy (with bone marrow impact) within 2 weeks of planned
apheresis or 3 half-lives, whichever is shorter.

5. Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection
(excluding fungal infections of nail beds) at study enrollment necessitating specific
treatment, or any major episode of infection requiring treatment with Intravenous (IV)
antimicrobials (e.g., IV antibiotics) or hospitalization (relating to completion of
antibiotic course).

6. Has known active central nervous system metastases. Subjects with previously treated
brain metastases may participate upon medical monitor agreement.

7. In the Investigator's judgement, any other condition or reason the subject would not
complete the required study visits and procedures, and follow up visits, or comply
with the study requirements for participation.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 3/10/23. Questions regarding updates should be directed to the study team contact.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 11/2/22. Questions regarding updates should be directed to the study team contact.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 1/19/23. Questions regarding updates should be directed to the study team contact.

• Males, age 18-40 years old.
• Staff members and trainees within the Sports Medicine Division and Physical Medicine and Rehabilitation Departments of Mayo Clinic.

• Individuals under 18 or over 40 years old.
• Prior or current history of elbow joint pain, injury, or surgery such as elbow joint arthritis, prior/current elbow ulnar collateral ligament injury that required subject to take time off from sport, or history of any elbow surgery.

Eligibility last updated 8/31/21. Questions regarding updates should be directed to the study team contact.

• Male or female age ≥ 18 years.
• Prior diagnosis of multiple myeloma according to IMWG criteriaa , and measurable disease.
• Relapsed MM refractory to at least one IMiD, PI, and anti-CD38 antibody; patient does not need to be refractory to all three classes of treatment in the same LOT in order to be eligible.
  • Note: Refractory is defined as having progressive disease (PD) while on therapy or within 60 days following treatment.
  • Note: PD will be defined as one or more of the following based on the 2016 IMWG consensus criteria for response and minimal residual disease assessment in MM:
    • Increase of 25% from lowest confirmed response value in one or more of the following criteria:
    • Serum M-protein (absolute increase must be ≥ 0.5 g/dL);
    • Serum M-protein increase ≥ 1 g/dL, if the lowest M component was ≥ 5 g/dL;
    • Urine M-protein (absolute increase must be ≥ 200 mg/24 h);
    • In patients without measurable serum and urine M-protein levels, the difference between involved and uninvolved free light chain (FLC) levels (absolute increase must be > 10 mg/dL);
    • In patients without measurable serum and urine M-protein levels and without measurable involved FLC levels, bone marrow plasma-cell percentage irrespective of baseline status (absolute increase must be ≥ 10%);
    • Appearance of a new lesion(s), ≥ 50% increase from nadir in the sum of the products of the maximal perpendicular diameters of measured lesions of > 1 lesion, or ≥ 50% increase in the longest diameter of a previous lesion > 1 cm in short axis; ≥ 50% increase in circulating plasma cells (minimum of 200 cells per µL) if this is the only measure of disease.
• Relapsed or refractory to last anti-MM regimen.
• ECOG performance status ≤ 2.
• Receiving subsequent treatment after becoming TCR (but not necessarily the first subsequent treatment), where initiation of this treatment will define the index date.
• Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
• * If application of International Myeloma Working Group (IMWG) criteria for diagnosis of MM or assessment of response is not available as part of regular clinical practice, clinician assessment may be used. The specific criteria used will be documented in the case report form.

• Diagnosis of current smoldering MM, active plasma cell leukemia, amyloidosis, and Polyneuropathy, Organomegaly, Endocrinopathy, Monoclonal protein, Skin changes (POEMS) syndrome.
• Prior stem cell transplant within 12 weeks prior to study enrollment or active graft-versus-host-disease (GVHD).
• Any other active malignancy within 3 years prior to study enrollment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ.
• No investigational drug within 30 days or 5 half-lives preceding the index date, and throughout course of the study.
• Prior or concomitant treatment with an anti-BCMA bispecific antibody, including PF-06863135.
• Currently pregnant or breastfeeding.
  • Note: Additional inclusion/exclusion criteria may be applied in a sensitivity analysis to more closely match the Phase 2 MagnetisMM-3 (study C1071003) trial population depending on available data.
• The following information will be collected at the time of enrollment to the extent data are available. Laboratory measurements will be based on the most recent reading at the time of enrollment:
  • Left ventricular ejection fraction (LVEF) > 40% by a multigated acquisition (MUGA) scan or echocardiogram (ECHO);
  • Adequate hepatic function;
  • Total bilirubin < 2 x upper limit of normal (ULN) (< 3 x ULN if documented Gilbert’s syndrome);
  • Aspartate transaminase (AST) < 2.5 x ULN; and
  • Alanine aminotransferase (ALT) < 2.5 x ULN;
  • Adequate renal function;
  • Creatinine clearance > 30 mL/min (according to the Cockcroft Gault formula, by 24-hour urine collection for creatinine clearance, or according to local institutional standard method;
  • Adequate bone marrow function o Absolute neutrophil count (ANC) > 1.0 x 10^9 /L;
  • Platelets > 25 x 10^9 /L; and
  • Hemoglobin > 8 g/dL;
  • Resolved acute effects of any prior therapy to baseline severity or Common Terminology Criteria for Adverse Events (CTCAE) Grade < 1.
• History of impaired cardiovascular function or clinically significant cardiovascular diseases (CVD), defined as any of the following within 6 months prior to study enrollment:
  • Acute myocardial infarction (AMI) or acute coronary syndromes (e.g., unstable angina, coronary artery bypass graft, coronary angioplasty or stenting, symptomatic pericardial effusion);
  • Clinically significant cardiac arrhythmias (e.g., uncontrolled atrial fibrillation or uncontrolled paroxysmal supraventricular tachycardia);
  • Thromboembolic or cerebrovascular events (e.g., transient ischemic attack, cerebrovascular accident, deep vein thrombosis [unless associated with a central venous access complication] or pulmonary embolism);
  • Prolonged QT syndrome (or triplicate average QTc corrected using Fridericia’s formula [QTcF] > 470 msec at screening);
  • Presence of ongoing Grade > 2 peripheral sensory or motor neuropathy;
  • History of any grade peripheral sensory or motor neuropathy, collected among patients with prior BCMA-directed therapy;
  • History of Guillain-Barré syndrome (GBS) or GBS variants, or history of any Grade > 3 peripheral motor polyneuropathy.
• Presence of surgical (including major surgery within 14 days prior to study enrollment), medical or psychiatric conditions including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator’s judgment, make the individual inappropriate for the study.
• Presence of active hepatitis B virus (HBV), hepatitis C virus (HCV), SARS-CoV-2, human immunodeficiency virus (HIV), or uncontrolled infection. Active infections must be resolved at least 14 days prior to study enrollment.
• Prior treatment with investigational drug within 30 days or 5 half-lives preceding the index date.

Eligibility last updated 2/14/22. Questions regarding updates should be directed to the study team contact.

• Male or female patients, aged 18 years and older.
• Scheduled to undergo gastric surgery for obesity.
• Able to provide written informed consent before participating in the study.
• Able to communicate adequately with the investigator and to comply with the requirements for the entire study.

• Individuals < 18 years old.
• Clinical evidence of significant cardiovascular, respiratory, renal, hepatic, gastrointestinal, hematological, neurological, psychiatric or other disease that may interfere with the objectives of the study.
• Medications. Opiates and high doses of anticholinergic agents (e.g., amitriptyline greater than 50 mg daily).
• Any other condition or prior therapy that, in the opinion of the investigator, would make the patient unsuitable for the study.

Eligibility last updated 9/1/21. Questions regarding updates should be directed to the study team contact.

• Male or female, at least 18 years old.
• Subjects with diagnosis of Hidradenitis Suppurativa (HS) and at least one active inflammatory lesion (nodule, abscess or tunnel) and has indication for deroofing or surgery.
• Subject must be in general good health without uncontrolled significant co-morbid conditions (except for hidradenitis suppurativa) as judged by the investigator, based on medical history.
• Has/will have undergone surgery for HS treatment at the Department of Dermatology, Mayo Clinic between September 2021 and December 31, 2022

• Individuals < 18 years old.

Eligibility last updated 9/10/21. Questions regarding updates should be directed to the study team contact.

-           -          

• Current use of any biologics, mast cell stabilizer or investigational drug within 4 weeks prior to skin sample, or 5 pharmacokinetic/pharmacodynamics half-lives, if known (whichever is longer)
• Patients who have the comorbidities listed below:
  • Mast cell disorder
  • Active infection
  • Malignancy
  • Pregnancy
  • Major dermatitis (e.g. atopic dermatitis, psoriasis)
• Patients whose records are incomplete

• 18 years of age or older at time of consent.
• Identified with one of 3 Post-Covid Syndrome (PASC) phenotypes at Mayo Clinic Rochester:  
  • fatigue-predominant  (N=20);
  • pain-predominant  (N=20); 
  • orthostasis-predominant  (N=20).
• Not pregnant by subject self-report at time of consent.
• Have the ability to provide informed consent.
• Have the ability to complete all aspects of this trial.
• Have access to an iPhone, iPad, or Android device.  
• Have no contraindicating comorbid health condition which would interfere with the proper use of the Muse-S™ system, as determined by the clinical investigators.

• Individuals < 18 years old.
• Used an investigational drug within the past 30 days.
• Anyone that is not on a stable dose of medication for anxiety, depression or sleep.
• Currently (within the past 3 weeks) been practicing mindfulness training on a weekly/regular basis.
• Currently (within 3 weeks) has been enrolled in another clinical or research program which intervenes on the patients’ QOL, or stress.
• An unstable medical or mental health condition as determined by the physician investigator.

Eligibility last updated 2/1/22. Questions regarding updates should be directed to the study team contact.

Subjects who meet all the following criteria will be eligible for the study:

• Women and men between 18 and 85 years of age.
• Have a diagnosis of interstitial lung disease (ILD) according to the American Thoracic Society Guidelines.
• Have a chronic cough for at least 3 months prior to the screening visit.
• Patients should be on a stable dose of ILD-directed therapies for 3 months prior to enrollment and will be allowed to continue their ILD-directed therapies. These include –but are not limited to- corticosteroids, immunosuppressing agents such as azathioprine and mycophenolate, as well as antifibrotic medications including nintedanib and pirfenidone. Additional corticosteroids and adjustment of ILD-directed therapy doses is permitted if deemed appropriate by the treating physician.
• Have a score of ≥ 40mm on the Cough Severity VAS at Screening..
• Women of child-bearing potential must use 2 forms of acceptable birth control and make no donation of eggs from Screening through the end of the 8-week study period. Acceptable birth control methods include established use of oral, injected, or implanted hormonal methods of contraception; intrauterine device (IUD) or intrauterine system (IUS); tubal ligation; or male sterilization. Double-barrier method (diaphragm for female subject and condom for male partner with spermicidal) satisfies the requirement for 2 forms of acceptable birth control. When concordant with the preferred lifestyle of the subject, true and complete abstinence (not periodic abstinence) is acceptable.
• Male subjects and their partners of child-bearing potential must use 2 methods of acceptable birth control, 1 of which must be a barrier method, and make no donation of sperm from Screening until 3 months after the last dose of study drug at the end of 8 weeks.
• Have provided written informed consent.
• Are willing and able to comply with all aspects of the protocol.

Subjects are NOT eligible for this study if they meet any of the following criteria:

• Current smoker (cigarettes, e-cigarettes or marijuana) or former smokers who have smoked within the past 12 months.
• Former smokers with > 20 pack-year history of smoking.
• Ongoing treatment with an ACE-inhibitor that is considered as the potential cause of a subject’s cough or requiring treatment with an ACE-inhibitor during the study or within 12 weeks prior to the Screening/Baseline Visit (Day -14 to Day 0).
• History of upper or lower respiratory tract infection or recent significant change in pulmonary status within 4 weeks of the Screening/Baseline Visit (Day -14 to Day 0).
• History of opioid use specifically prescribed for chronic cough within 2 weeks of the Screening/Baseline Visit (Day -14 to Day 0). Use of opioids for other indications (for example, to treat pain) is permitted.
• History of baclofen use specifically prescribed for chronic cough within 2 weeks of the Screening/Baseline Visit (Day -14 to Day 0). Use of baclofen for other indications (for example, to treat spasticity) is permitted.
• Presence of an untreated or undertreated cause (other than ILD) for the patient’s chronic cough (per ACCP guidelines). e.g. uncontrolled asthma, GERD or post-nasal drainage that could potentially explain the patient’s chronic cough.
• Requiring concomitant therapy with prohibited medications.
• Treatment with any pharmaceutical or biological investigational therapy (excluding COVID vaccination and COVID related monoclonal antibody therapy).
• Participation in another clinical trial that does not allow co-enrollment within 4 weeks prior to the Screening/Baseline Visit (Day -14 to Day 0).
• Total bilirubin, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3x the upper limit of normal (ULN) during screening.
• Serum creatinine < 30 mL/min, hemodialysis or peritoneal dialysis.
• Advanced liver disease as defined by the presence of cirrhosis and/or signs of portal hypertension.
• History of previous hypersensitivity or intolerance to Duloxetine & Amitriptyline (patients who have previously been on either amitriptyline or duloxetine for chronic cough or other reasons and have tolerated the medication will be offered participation regardless of previous response to therapy).
• Currently pregnant or breastfeeding female subject.
• Presence of any medical condition or disability that the investigators believe could interfere with the assessment of safety or efficacy in this trial or compromise the safety of the subject.
• Planned or anticipated major surgical procedure or other activity that would interfere with the subject’s ability to comply with protocol-mandated assessments (e.g., extended travel) during the subject’s participation in the study. 
• Currently taking either another SSRI, SNRI or MAO inhibitor which the patient cannot safely discontinue at least 2 weeks prior to the screening period.

Eligibility last updated 6/3/22. Questions regarding updates should be directed to the study team contact.

• Voluntary and valid written informed consent to participate in the trial provided by the patient before any trial related procedures are performed.
• Male or female patient, ≥ 18 years at screening.
• Diagnosis of PLD (associated with ADPKD or isolated as in ADPLD) as defined by htTLV ≥ 2500 mL/m at screening.
• Presence of at least 1 of the following PLD-related symptoms within 2 weeks before screening: bloating, fullness in abdomen, lack of appetite, feeling full quickly after beginning to eat, acid reflux, nausea, rib cage pain or pressure, pain in side, abdominal pain, back pain, shortness of breath after physical exertion, limited in mobility, concern about abdomen getting larger, dissatisfied by the size of abdomen.
• Not a candidate for, or not willing to undergo, surgical intervention for hepatic cysts during the trial.
• Female patients of childbearing potential must be willing to use an acceptable method of contraception from screening and during the entire trial.
• Male patients must be willing to use condom as method of contraception from screening and throughout the trial unless they have been sterilized by vasectomy (with an appropriate post-vasectomy documentation of the absence of sperm in the ejaculate).

• Surgical intervention for PLD within 3 months before screening.
• Treatment with an SSA within 3 months before screening.
• Non-responsive to previous treatment of PLD with an SSA as per the Investigator’s assessment.
• Cholelithiasis within 3 months before screening or previous medical history of cholelithiasis induced by SSAs unless treated with cholecystectomy.
• Presence of extrahepatic cysts that, in the Investigator’s opinion, may prevent the patient from safely participating in the trial.
• Severe kidney disease, as defined by estimated glomerular filtration rate (eGFR) 160 mmHg and/or diastolic blood pressure of >100 mmHg at screening.
• Severe liver disease defined as liver cirrhosis of Child-Pugh class C.
• Use of oral contraceptives or estrogen supplementation within 3 months before screening.
• Poorly controlled diabetes (hemoglobin A1c ≥ 10%) at screening.
• Patients with a known history of hypothyroidism, unless they have been on adequate and stable replacement thyroid hormone therapy for at least 3 months before the first dose of the IMP.
• Uncontrolled hypertension defined by a systolic blood pressure of > 160 mmHg and/or diastolic blood pressure of > 100 mmHg at screening
• History of significant cardiac disease or current diagnosis of cardiac disease indicating significant risk of safety for patients participating in the trial, such as uncontrolled or significant cardiac disease, including any of the following:
  • History of myocardial infarction, angina pectoris or coronary artery bypass graft within 6 months before screening;
  • Clinically significant cardiac arrhythmias (e.g., ventricular tachycardia), complete left bundle branch block or high-grade atrioventricular block (e.g., bifascicular block, Mobitz type II and third-degree atrioventricular block);
  • Long QT syndrome, family history of idiopathic sudden death or congenital long QT syndrome, or any of the following:
  • Risk factors for Torsades de Pointes including uncorrected hypokalemia or hypomagnesemia, history of cardiac failure or history of clinically significant/symptomatic bradycardia;
  • Treatment with concomitant medication(s) with a "Known risk of Torsades de Pointes" per www.crediblemeds.org that cannot be discontinued or replaced by safe alternative medication at least 5 half-lives or 7 days (whichever is longer) before the first dose of IMP;
  • Patients with a baseline QTc interval corrected by Fridericia's formula (QTcF) > 450 msec for males and > 470 msec for females at screening.
• Patients with vascular compromise, including, but not limited to, mesenteric thrombosis, portal hypertension and thrombocytopenia (platelet counts less than 100 x 10^9 /L).
• Pregnant, lactating or planning to be pregnant during the trial.
• Clinically significant laboratory abnormalities, which in the opinion of the Investigator may prevent the patient from safely participating in the trial.
• History of solid organ transplantation.
• Any known allergy, hypersensitivity or intolerance to octreotide or any related drug, or other components of CAM2029, or history of any drug hypersensitivity or intolerance that, in the opinion of the Investigator, would compromise the safety of the patient.
• Contraindications to, or interference with, MRI assessments, as dictated by local hospital regulations.
• Previously treated/randomized in the current clinical trial.
• Participation in any other clinical trial to test an investigational drug or device within the last 30 days before screening or during the trial.
• Any other contraindicated serious medical condition that, in the Investigator’s opinion, may prevent the patient from safely participating in the trial.
• Any other current or prior medical condition that may interfere with the conduct of the trial or the evaluation of its results in the opinion of the Investigator.
• Unwilling or unable to comply with the requirements of the protocol or in a situation or condition that, in the opinion of the Investigator, may interfere with participation in the trial.
• On the staff, affiliated with, or a family member of the personnel directly involved with this trial.

Eligibility last updated 9/10/21. Questions regarding updates should be directed to the study team contact.