Actively Recruiting
A First-in-Human, Phase I/II PET Imaging Study of 64Cu-GRIP B, a Radiotracer Targeting Granzyme B, in Patients With Advanced Malignancies
Led by Rahul Aggarwal · Updated on 2026-03-17
91
Participants Needed
1
Research Sites
4 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
Researchers are evaluating the use of a radiotracer called 64Cu-GRIP B with PET imaging to detect granzyme B, a biomarker produced by immune cells during immunotherapy, in patients with advanced cancers that have spread to nearby tissues or lymph nodes. This phase I/II study focuses on genitourinary cancers, including renal cell carcinoma, urothelial cancer, and metastatic castration-resistant prostate cancer, aiming to assess safety and usefulness of the imaging in monitoring immune response. Participants are divided into four groups based on cancer type: metastatic genitourinary malignancies, renal cell and urothelial carcinoma, metastatic castration-resistant prostate cancer, and other solid tumors. All receive the 64Cu-GRIP B injection followed by PET scans at baseline. Some groups have additional scans at 8 weeks and at disease progression. Imaging methods include PET/CT or PET/MRI, with safety monitoring conducted at multiple time points after tracer injection. During the study, patients undergo scans, blood sampling, and tumor biopsies when applicable. Researchers monitor adverse events, tracer distribution, and tumor uptake patterns over time. Outcomes measured include safety, tracer pharmacokinetics, changes in tumor uptake values, and correlations with clinical outcomes such as response to immunotherapy and progression-free survival. Participants are followed for up to two years to assess long-term effects and disease progression.
CONDITIONS
Brief Title
64Cu-GRIP B in Patients With Advanced Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed metastatic solid tumor malignancy for Cohort A (3 males, 3 females)
- Locally advanced or metastatic disease on conventional imaging
- Histologically confirmed metastatic renal cell carcinoma or urothelial carcinoma 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 safely 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
- Age 18 years or older at study entry
- Adequate organ function including creatinine clearance > 60 mL/min, bilirubin ≤ 1.5 x upper limit of normal, 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 give valid informed consent due to age, medical or psychiatric condition, or physiologic status
- Any condition that impairs ability to comply with study procedures
- Currently pregnant or breastfeeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 8 weeks
Participants receive 64Cu-GRIP B PET scans to evaluate tumor uptake and assess safety, dosimetry, and pharmacokinetics of the radiotracer.
1 baseline PET scan; additional PET scans at 60 minutes, 2 hours, and 24 hours after injection for safety monitoring
Duration - Up to 2 years
Participants in certain cohorts undergo additional PET scans at 8 weeks and at disease progression to monitor tumor response and disease status over time.
Additional PET scans at 8 weeks and at progression depending on cohort; longitudinal follow-up visits for safety and outcomes
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
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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