64Cu-GRIP B in Patients With Advanced Malignancies
Phase 1/2
91
about 3.7 years
18+
1 site in CA
What this study is about
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.
Simplified from trial records by PatientMatch.
What you may be asked to do
- 1.Take Copper-64 labeled Granzyme B (64Cu-GRIP B)
- 2.Undergo Positron Emission Tomography (PET)
Participation Burden
What's physically and logistically required of participants.
Requires travel to a study site
How treatment is administered
Everyone gets the investigational treatment.
Extracted study details
Pulled from the trial record to show what is being tested and what the study is measuring.
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