Phase 1 Study of 68Ga-R8760

Trial Title: Phase 1 Study of 68Ga-R8760

NCT ID: NCT05999292

Condition: Adrenocortical Carcinoma

Conditions: Official terms:
Carcinoma
Adrenocortical Carcinoma

Conditions: Keywords:
Adrenocortical Carcinoma

Study type: Interventional

Study phase: Phase 1

Overall status: Active, not recruiting

Study design:

Allocation: Non-Randomized

Intervention model: Sequential Assignment

Primary purpose: Diagnostic

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: 68Ga-R8760 injection at pre-defined dose levels
Description: PET/CT imaging at predefined timepoints
Arm group label: 68Ga-R8760 Dose Selection (Part 1)

Intervention type: Drug
Intervention name: 68Ga-R8760 injection
Description: PET/CT imaging at a single timepoint
Arm group label: 68Ga-R8760 Expansion Cohort (Part 2)

Summary: A Phase 1 Safety and Dosimetry Study of 68Ga-R8760 in Patients with Adrenocortical Carcinoma and Healthy Volunteers

Criteria for eligibility:
Criteria:
Adrenocortical Carcinoma Subjects Inclusion Criteria: 1. Pathologically or clinically confirmed ACC. 2. Newly diagnosed or recurrent/relapsed ACC with at least 1 measurable target lesion per RECIST v1.1 criteria. 3. Male or non-pregnant, non-lactating female subjects age ≥18 years. 4. Female subjects of childbearing potential and male subjects (if sexually active) must agree to use adequate method(s) of effective contraception during their participation in the study. 5. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤2. 6. Adequate hepatic function as defined below: 1. Serum alanine aminotransaminase (ALT)/ aspartate aminotransaminase (AST) ≤3 × upper limit of normal (ULN) or ≤5 × ULN if liver metastases are present or received prior mitotane therapy, and 2. Serum bilirubin - total ≤1.5 × ULN (unless due to Gilbert's syndrome or hemolysis in which case total ≤3.0 × ULN). 7. Adequate renal function as measured by creatinine clearance calculated by the Cockcroft-Gault formula (≥60 mL/minute). 8. Able to understand and willing to sign a written informed consent form. Exclusion Criteria: 1. Administered a radionuclide within a period of time corresponding to less than 10 physical half-lives of the radionuclide prior to study Day 1. 2. Radiotherapy ≤14 days prior to study Day 1. 3. Major surgery ≤21 days prior to study Day 1 or has not recovered from adverse effects of such procedure. 4. Severe or unstable medical condition, such as congestive heart failure (New York Heart Association [NYHA] Class III or IV), ischemic heart disease, uncontrolled hypertension, uncontrolled diabetes mellitus, as well as an uncontrolled cardiac arrhythmia requiring medication (≥Grade 2, according to NCI-CTCAE Version 5.0), myocardial infarction within 6 months prior to starting study drug, or any other significant or unstable concurrent cardiac illness. Note: Stable chronic atrial fibrillation is allowed. 5. Congenital long QT syndrome or corrected QT interval by Fridericia (QTcF) interval >450 msec (males) or >470 msec (females). 6. History of cerebrovascular accident within 6 months or that resulted in ongoing neurologic instability. 7. History of other previous or concurrent cancer that would interfere with the determination of safety. 8. Major active infection requiring antibiotics. 9. Known active human immunodeficiency virus infection or active infection with Hepatitis B or C. 10. Acute illness within 14 days prior to study Day 1unless mild in severity, as assessed by the Investigator. 11. Any other condition that in the opinion of the Investigator would place the subject at an unacceptable risk or cause the subject to be unlikely to fully participate or comply with study procedures. Healthy Volunteers Inclusion Criteria: 1. Healthy male or non-pregnant, non-lactating female subjects aged between 18 and 59 years (inclusive). 2. Female subjects of childbearing potential and male subjects (if sexually active) must agree to use adequate method(s) of effective contraception during their participation in the study. 3. Body mass index between 18.0 and 32.0 kg/m2 (inclusive). 4. Adequate renal function as measured by creatinine clearance calculated at ≥60 mL/minute by the Cockcroft-Gault formula. 5. Able to understand and willing to sign a written informed consent form. Exclusion Criteria: 1. Prior unilateral or bilateral adrenalectomy. 2. Mental or legal incapacitation. 3. History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator (or designee). 4. Subjects diagnosed with adrenal disease, including Cushing's syndrome, adrenal insufficiency, or congenital adrenal hyperplasia. 5. Glucocorticoid steroid use (including topical) within 4 weeks prior to study Day 1 (inhaled steroids are allowed). 6. Active or recent (within 30 days of screening) infection or history of recurrent chronic infections with underlying condition that may predispose one to infections. 7. Resting pulse rate ≥100 or <40 beats per minute at screening. If abnormal, a repeat measurement will be conducted to confirm. 8. Systolic blood pressure >160 or <90 mmHg or diastolic blood pressure >90 or <50 mmHg, unless judged by the Investigator to have no clinical significance. 9. Participation in a clinical study involving administration of an investigational drug in the past 30 days or 5 half-lives (whichever is longer) prior to study Day 1. 10. Administered a radionuclide within a period of time corresponding to less than 10 physical half-lives of the radionuclide prior to study Day 1. 11. Donation of blood or significant blood loss within 3 months prior to screening, donation of plasma within 2 weeks prior to screening, or donation of platelets within 6 weeks prior to screening.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: Accepts Healthy Volunteers

Locations:

Facility:
Name: University of Michigan Nuclear Medicine

Address:
City: Ann Arbor
Zip: 48109
Country: United States

Facility:
Name: MD Anderson Cancer Center

Address:
City: Houston
Zip: 77030
Country: United States

Start date: September 11, 2023

Completion date: September 30, 2024

Lead sponsor:
Agency: Radionetics Oncology
Agency class: Industry

Source: Radionetics Oncology

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05999292