Adrenocortical Carcinoma
Conditions
Keywords
Adrenocortical Carcinoma
Brief summary
A Phase 1 Safety and Dosimetry Study of 68Ga-R8760 in Patients with Adrenocortical Carcinoma and Healthy Volunteers
Interventions
DRUG68Ga-R8760 injection at pre-defined dose levels
PET/CT imaging at predefined timepoints
DRUG68Ga-R8760 injection
PET/CT imaging at a single timepoint
Sponsors
Radionetics Oncology
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of adverse events characterized overall and by type, frequency, seriousness, relationship to study drug, timing and severity graded according to the NCI-CTCAE v5.0; absolute values and changes in clinical laboratory parameters | 7 days |
| Absorbed dose coefficients (milliGray [mGy]/megabecquerel [MBq]) in organs | 1 day |
| The effective dose (milliSievert [mSv]/MBq) | 1 day |
Secondary
| Measure | Time frame |
|---|---|
| Area under the plasma concentration versus time curse (AUC) | 1 day |
| Number and location of tumors identified by 68Ga-R8760 PET/CT and by anatomic images | 1 day |
| Half-life (T1/2) of 68Ga-R8760 | 1 day |
| Maximum plasma concentration (Cmax) | 1 day |
| Maximum standard uptake value (SUVmax) of each tumor and of source organ | 1 day |
| Ratio of the tumor SUV over reference region SUV | 1 day |
Countries
United States
Outcome results
None listed