Actively Recruiting
64Cu-GRIP B in Patients With Advanced Malignancies
Led by Rahul Aggarwal · Updated on 2026-03-17
91
Participants Needed
1
Research Sites
192 weeks
Total Duration
On this page
Sponsors
R
Rahul Aggarwal
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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 positron emission tomography (PET) imaging can be safe and useful for detecting granzyme B (GrB) in patients with advanced cancers that has spread to nearby tissue or lymph nodes (advanced). Granzyme B (GrB) is a biomarker produced by immune cells in response to immunotherapy, which may highlight tumors that are more likely to respond to treatment. The study population is focused on genitourinary (GU) malignancies, including renal cell and urothelial cancer, two tumor types with high mutational burden and tumor infiltrating lymphocytes compared to other tumor types, and have a predictable response rate at the population level to immune checkpoint inhibitors. The information gained from this trial may allow researchers to develop future trials where 64Cu-GRIP B PET may serve as a biomarker to monitor early response to immunomodulatory therapies which are used to stimulate or suppress the immune system and may help the body fight cancer.
CONDITIONS
Official Title
64Cu-GRIP B in Patients With Advanced Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 years or older at study entry
- Histologically-confirmed metastatic solid tumor malignancy for Cohort A (3 males, 3 females)
- Histologically-confirmed metastatic renal cell carcinoma or urothelial carcinoma with locally advanced or metastatic disease for Cohort B
- Histologically-confirmed prostate adenocarcinoma with metastatic castration-resistant prostate cancer for Cohort C
- Planned treatment with immune checkpoint inhibitor for Cohorts B and C
- Willingness to undergo paired tumor biopsies with accessible bone or soft tissue lesion for Cohorts B and C
- Ability and willingness to comply with study procedures and provide informed consent
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Adequate organ function including serum creatinine ≤1.5 times upper limit of normal or creatinine clearance >60 mL/min, total bilirubin ≤1.5 times upper limit of normal (less than 3 times for Gilbert's syndrome), hemoglobin ≥8.0 g/dL, platelet count ≥75,000/microliter, and absolute neutrophil count ≥1000/microliter
- Not pregnant or breastfeeding; women of childbearing potential must have a negative pregnancy test within 14 days of PET scan and use effective contraception
You will not qualify if you...
- Unable to provide valid informed consent due to age, medical, or psychiatric conditions
- Any condition impairing the ability to comply with study procedures as determined by the Principal Investigator
- Currently pregnant or breastfeeding
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of California, San Francisco
San Francisco, California, United States, 94143
Actively Recruiting
Research Team
J
Jessie Huang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
4
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