64Cu-GRIP B in Patients With Advanced Malignancies
Phase 1/2
91
about 3.7 years
18+
1 site in CA
About this study
This trial is testing 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. It 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.
Based on ClinicalTrials.gov records.
What participants do
- 1.Take Copper-64 labeled Granzyme B (64Cu-GRIP B)
- 2.Undergo Positron Emission Tomography (PET)
Participation effort
Estimated from trial records. Details can vary by site.
Logistics difficulty varies by site location and availability.
Trial highlights
Treatment details
Auto-extracted from trial records to preview treatments and outcomes.
Dermatological Agents
Primary: AUC extrapolated to infinity (Cohort A), Apparent terminal elimination half-life (Cohort A), Area under the concentration-time curve (AUC) (Cohort A), Frequency of treatment-emergent adverse events (Cohort A), Maximum observed concentration (Cmax) (Cohort A), Median clearance (Cohort A), Time to maximum observed concentration (Tmax) (Cohort A)
Secondary: Association of baseline uptake with object response (ORR) (Cohorts B, C and D), Association of baseline uptake with progression-free survival (PFS) (Cohorts B, C and D), Association of baseline uptake with reported immune-related adverse events (irAEs)(Cohorts B, C and D), Frequency of treatment-emergent adverse events (Cohorts B, C, and D), Median change in SUVmax from baseline with reported immune-related adverse event (Cohort B), Median change in SUVmax-ave from baseline with reported immune-related adverse event (Cohorts B)
imaging
Oncology