Phase 1 Study of 68Ga-R8760 (NCT05999292) | Clinical Trial Compass
TerminatedPhase 1
Phase 1 Study of 68Ga-R8760
Stopped: Sponsor decision
United States11 participantsStarted 2023-09-11
Plain-language summary
A Phase 1 Safety and Dosimetry Study of 68Ga-R8760 in Patients with Adrenocortical Carcinoma and Healthy Volunteers
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Pathologically or clinically confirmed ACC.
✓. Newly diagnosed or recurrent/relapsed ACC with at least 1 measurable target lesion per RECIST v1.1 criteria.
✓. Male or non-pregnant, non-lactating female subjects age ≥18 years.
✓. 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.
✓. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤2.
✓. Adequate hepatic function as defined below:
✓. 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
✓. Serum bilirubin - total ≤1.5 × ULN (unless due to Gilbert's syndrome or hemolysis in which case total ≤3.0 × ULN).
Exclusion criteria
✕. Administered a radionuclide within a period of time corresponding to less than 10 physical half-lives of the radionuclide prior to study Day 1.
✕. Radiotherapy ≤14 days prior to study Day 1.
✕. Major surgery ≤21 days prior to study Day 1 or has not recovered from adverse effects of such procedure.
✕
What they're measuring
1
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
Timeframe: 7 days
2
Absorbed dose coefficients (milliGray [mGy]/megabecquerel [MBq]) in organs
. 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.
✕. Congenital long QT syndrome or corrected QT interval by Fridericia (QTcF) interval \>450 msec (males) or \>470 msec (females).
✕. History of cerebrovascular accident within 6 months or that resulted in ongoing neurologic instability.
✕. History of other previous or concurrent cancer that would interfere with the determination of safety.