This phase I/II clinical trial evaluates if using a radiotracer called 64 Cu-GRIP B with positron emission tomography (PET) imaging can be safe and useful for detecting granzyme B (GrB) in patients with solid tumor cancers that have spread to nearby tissue or lymph nodes (advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic). 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 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.
Additional locations may be listed on ClinicalTrials.gov for NCT05888532.
Locations matching your search criteria
United States
California
San Francisco
University of California San FranciscoStatus: Active
Contact: Rahul Raj Aggarwal
Phone: 415-353-9278
PRIMARY OBJECTIVES:
I. To determine the safety, dosimetry, and pharmacokinetics of copper Cu 64 GRIP B (64Cu-GRIP B) PET in patients with solid tumor malignancies (3 males, 3 females). (Cohort A)
II. To determine the mean percent change in both tumor maximum standardized uptake value (SUVmax) and ratio of SUVmax//blood average standardized uptake value (SUVave) on 64Cu-GRIP B PET in patients with participants with metastatic renal cell carcinoma (RCC) and urothelial carcinoma (UC) (Cohort B) or metastatic castration-resistant prostate cancer (mCRPC) (Cohort C).
SECONDARY OBJECTIVES:
I. To determine the safety and average organ dosimetry of 64Cu-GRIP B PET in patients with participants with metastatic RCC and UC (Cohort B), mCRPC (Cohort C) or other solid tumor malignancies (Cohort D).
II. To descriptively report the patterns of intra-tumoral uptake of 64Cu-GRIP B on whole body PET, including by site of disease, uptake by tumor type, inter-tumoral and inter-patient heterogeneity, and tumor-to-background signal at baseline and at the time of progression in patients with metastatic RCC and UC (Cohort B), mCRPC (Cohort C), or other solid tumor malignancies (Cohort D).
III. To descriptively report PET at grade >= 2 immune-related adverse event(s) in patients with metastatic RCC and UC (Cohort B) who have 64Cu-GRIP B PET performed within 14 days of onset of event.
IV. To descriptively report the number of lesions identified on 64Cu-GRIP B PET compared with conventional imaging in patients with participants with metastatic RCC and UC (Cohort B), mCRPC (Cohort C), or other solid tumor malignancies (Cohort D).
V. To determine whether baseline uptake on 64Cu-GRIP B PET is associated with subsequent clinical outcomes including objective response, progression-free survival, prostate-specific antigen 50% reduction (PSA50) response, and immune-related adverse events in participants with metastatic RCC and UC (Cohort B), mCRPC (Cohort C), or other solid tumor malignancies (Cohort D).
EXPLORATORY (CORRELATIVE) OBJECTIVE:
I. To determine the association between uptake on 64Cu-GRIP B PET with tissue and blood-based immune parameters in participants with metastatic RCC and UC (Cohort B), mCRPC (Cohort C), or other solid tumors (Cohort D).
OUTLINE: Patients are assigned to 1 of 4 cohorts.
COHORT A: Patients with solid tumors receive 64Cu-GRIP B intravenously (IV) and then undergo PET/computed tomography (CT) or PET/magnetic resonance imaging (MRI) at 0.5, 1, 4, and 24 hours after receiving 64Cu-GRIP B. Patients also undergo blood sample collection on study.
COHORT B: Patients with metastatic RCC or UC receive 64Cu-GRIP B IV and undergo PET/CT or PET/MRI at baseline, 8 weeks after baseline, at the time of grade >= 2 immune-related adverse events, and optionally at the time of progression. Patients also undergo tissue biopsy during screening and on study.
COHORT C: Patients with mCRPC receive 64Cu-GRIP B IV and undergo PET/CT or PET/MRI at baseline, 8 weeks after baseline, and optionally at the time of progression. Patients also undergo tissue biopsy during screening and on study.
COHORT D: Patients with other solid tumors receive 64Cu-GRIP B IV and undergo PET/CT or PET/MRI at baseline, at 8 weeks after baseline, and optionally at the time of progression. Patients also undergo tissue biopsy during screening and on study.
Lead OrganizationUniversity of California San Francisco
Principal InvestigatorRahul Raj Aggarwal
