64Cu-GRIP B in Patients With Advanced Malignancies (NCT05888532) | Clinical Trial Compass
RecruitingPhase 1/2
64Cu-GRIP B in Patients With Advanced Malignancies
United States91 participantsStarted 2023-05-25
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Disease characteristics by cohort, as defined by:
. Planned treatment with immune checkpoint inhibitor (Cohorts B and C only)
. Willing to undergo paired tumor biopsies and has safely accessible bone or soft tissue lesion (Cohorts B and C only)
. The subject is able and willing to comply with study procedures and provide signed and dated informed consent.
. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
. Age 18 years or older at the time of study entry.
. Adequate organ function, as defined by:
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Frequency of treatment-emergent adverse events (Cohort A)
Timeframe: Up to 8 weeks
2
Percent of injected activity (Cohort A)
Timeframe: Up to 8 weeks
3
Time to maximum observed concentration (Tmax) (Cohort A)
Timeframe: Up to 8 weeks
4
Maximum observed concentration (Cmax) (Cohort A)
Timeframe: Up to 8 weeks
5
Area under the concentration-time curve (AUC) (Cohort A)
Timeframe: Up to 8 weeks
6
AUC extrapolated to infinity (Cohort A)
Timeframe: Up to 8 weeks
7
Median clearance (Cohort A)
Timeframe: Up to 8 weeks
8
Apparent terminal elimination rate constant (Cohort A)
. Patients must not be pregnant or breast feeding. Women of childbearing potential are required to obtain a negative pregnancy test within 14 days of PET Imaging scan. Effective contraception (men and women) must be used in subjects of child-bearing potential.
Exclusion criteria
. Patients who because of age, general medical or psychiatric condition, or physiologic status cannot give valid informed consent.
. Any condition that, in the opinion of the Principal Investigator, would impair the patient's ability to comply with study procedures.
. Is currently pregnant or breastfeeding.
Timeframe: Up to 8 weeks
9
Apparent terminal elimination half-life (Cohort A)