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 range18 Years

SexALL

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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:
✓. 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.

What they're measuring

Frequency of treatment-emergent adverse events (Cohort A)

Timeframe: Up to 8 weeks

Percent of injected activity (Cohort A)

Timeframe: Up to 8 weeks

Time to maximum observed concentration (Tmax) (Cohort A)

Timeframe: Up to 8 weeks

Maximum observed concentration (Cmax) (Cohort A)

Timeframe: Up to 8 weeks

Area under the concentration-time curve (AUC) (Cohort A)

Timeframe: Up to 8 weeks

AUC extrapolated to infinity (Cohort A)

Timeframe: Up to 8 weeks

Median clearance (Cohort A)

Timeframe: Up to 8 weeks

Apparent terminal elimination rate constant (Cohort A)

Timeframe: Up to 8 weeks

Trial details

NCT IDNCT05888532

SponsorRahul Aggarwal

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12-31

Contact for this trial

Jessie Huang

877-827-3222 jessie.huang2@ucsf.edu

View on ClinicalTrials.gov More Prostate Cancer trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

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:
✓. 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.

What they're measuring

Frequency of treatment-emergent adverse events (Cohort A)

Timeframe: Up to 8 weeks

Percent of injected activity (Cohort A)

Timeframe: Up to 8 weeks

Time to maximum observed concentration (Tmax) (Cohort A)

Timeframe: Up to 8 weeks

Maximum observed concentration (Cmax) (Cohort A)

Timeframe: Up to 8 weeks

Area under the concentration-time curve (AUC) (Cohort A)

Timeframe: Up to 8 weeks

AUC extrapolated to infinity (Cohort A)

Timeframe: Up to 8 weeks

Median clearance (Cohort A)

Timeframe: Up to 8 weeks

Apparent terminal elimination rate constant (Cohort A)

Timeframe: Up to 8 weeks