Status:
RECRUITING
64Cu-GRIP B in Patients With Advanced Malignancies
Lead Sponsor:
Rahul Aggarwal
Collaborating Sponsors:
National Cancer Institute (NCI)
U.S. Army Medical Research Acquisition Activity
Conditions:
Prostate Cancer
Renal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This phase I/II clinical trial evaluates if using a radiotracer targeting granzyme B, 64-copper granzyme targeting restricted interaction peptide specific to family member B (64 Cu-GRIP B) with positr...
Detailed Description
PRIMARY OBJECTIVES: I. To determine the safety, dosimetry, and pharmacokinetics of 64Cu-GRIP B PET in patients with solid tumor malignancy (3 males, 3 females). (Cohort A) II. To determine the mean p...
Eligibility Criteria
Inclusion Criteria:
-
Disease characteristics by cohort, as defined by:
Cohort A:
- Histologically-confirmed metastatic solid tumor malignancy (3 Male, 3 Female)
- Locally advanced or metastatic disease on conventional imaging
Cohort B:
- Histologically-confirmed metastatic renal cell carcinoma (any histologic sub-type) or urothelial carcinoma
- Locally advanced or metastatic disease on conventional imaging
Cohort C:
- Histologically-confirmed prostate adenocarcinoma
- Metastatic castration resistant prostate cancer by Prostate Cancer Clinical Trials Working Group 3 (PCWG3) criteria
-
Planned treatment with immune checkpoint inhibitor (Cohorts B and C only)
-
Willing to undergo paired tumor biopsies and has safely accessible bone or soft tissue lesion (Cohorts B and C only)
-
The subject is able and willing to comply with study procedures and provide signed and dated informed consent.
-
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
-
Age 18 years or older at the time of study entry.
-
Adequate organ function, as defined by:
- Serum creatinine <= 1.5 x upper limit of normal (ULN) or estimated creatinine clearance > 60 mL/min
- Total bilirubin <= 1.5 x ULN (< 3 x ULN in patients with documented or suspected Gilbert's).
- Hemoglobin >= 8.0 g/dL
- Platelet count >= 75,000/microliter
- Absolute neutrophil count ≥ 1000/microliter
-
Patients must not be pregnant or breast feeding. Women of childbearing potential are required to obtain a negative pregnancy test within 14 days of PET Imaging scan. Effective contraception (men and women) must be used in subjects of child-bearing potential.
Exclusion Criteria:
- Patients who because of age, general medical or psychiatric condition, or physiologic status cannot give valid informed consent.
- Any condition that, in the opinion of the Principal Investigator, would impair the patient's ability to comply with study procedures.
- Is currently pregnant or breastfeeding.
Key Trial Info
Start Date :
May 25 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 31 2027
Estimated Enrollment :
91 Patients enrolled
Trial Details
Trial ID
NCT05888532
Start Date
May 25 2023
End Date
January 31 2027
Last Update
March 17 2026
Active Locations (1)
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1
University of California, San Francisco
San Francisco, California, United States, 94143