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64Cu-GRIP B Imaging for Advanced Cancers

This study is testing a new imaging method using Copper-64 labeled Granzyme B (64Cu-GRIP B) and a PET scan (Positron Emission Tomography, a type of imaging) for people with advanced cancers like prostate, kidney (renal), or bladder (urethral) cancer. The goal is to see if this imaging is safe and can help detect Granzyme B, a marker produced by immune cells that might show if a tumor will respond to immunotherapy (treatment that uses your body's own immune system). The study will look at how safe 64Cu-GRIP B is, how it moves through the body, and how well it highlights tumors. You may be eligible if you are 18 or older with certain advanced solid tumors that have spread.

Study design
This is an interventional study with a planned enrollment of 91 participants. It is not specified if it is randomized or blinded.
What's involved
You would receive an intravenous (IV) injection of Copper-64 labeled Granzyme B (64Cu-GRIP B) before undergoing a PET imaging procedure.
Compensation
Not stated in the trial record.
Follow-up
Your safety and other measures will be monitored for up to 8 weeks after the intervention.

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NCT05888532

64Cu-GRIP B in Patients With Advanced Malignancies

Recruiting
PHASE1Ages 18+InterventionalDiagnostic
Rahul Aggarwal
~91 participants
Updated 2026-03-17 on ClinicalTrials.gov
What's tested:Copper-64 labeled Granzyme B (64Cu-GRIP B)Positron Emission Tomography (PET)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Frequency of treatment-emergent adverse events (Cohort A)
Measured over Up to 8 weeks
+10 more outcomes measured

Conditions

Prostate Cancer
Renal Cancer
Urethral Cancer
Advanced Solid Tumor
Metastatic Castration-resistant Prostate Cancer
Solid Tumor, Adult

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Prostate CarcinomaRenal Cell CarcinomaSolid NeoplasmUrothelial Carcinoma

Where it's being run

1 sites across 1 states
California1

Study leadership

  • Rahul Aggarwal, MD · PRINCIPAL_INVESTIGATOR · University of California, San Francisco

Who to contact

Jessie Huang
[email protected]
877-827-3222
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Histologically-confirmed metastatic solid tumor malignancy (3 Male, 3 Female)
Locally advanced or metastatic disease on conventional imaging
Histologically-confirmed metastatic renal cell carcinoma (any histologic sub-type) or urothelial carcinoma
Locally advanced or metastatic disease on conventional imaging
Histologically-confirmed prostate adenocarcinoma
Metastatic castration resistant prostate cancer by Prostate Cancer Clinical Trials Working Group 3 (PCWG3) criteria 2. Planned treatment with immune checkpoint inhibitor (Cohorts B and C only) 3. Willing to undergo paired tumor biopsies and has safely accessible bone or soft tissue lesion (Cohorts B and C only) 4. The subject is able and willing to comply with study procedures and provide signed and dated informed consent. 5. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. 6. Age 18 years or older at the time of study entry. 7. Adequate organ function, as defined by:
Serum creatinine \<= 1.5 x upper limit of normal (ULN) or estimated creatinine clearance \> 60 mL/min
Total bilirubin \<= 1.5 x ULN (\< 3 x ULN in patients with documented or suspected Gilbert's).
Hemoglobin \>= 8.0 g/dL
Platelet count \>= 75,000/microliter
Absolute neutrophil count ≥ 1000/microliter 8. 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.

What this trial measures

  • Frequency of treatment-emergent adverse events (Cohort A)Up to 8 weeks

    For Cohort A, the frequency and severity of adverse events following 64Cu-GRIP B injection will be descriptively reported, using NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0

  • Percent of injected activity (Cohort A)Up to 8 weeks

    For Cohort A, the tracer kinetics is measured in the organs and total-body, and the % of injected activity for each time point will be recorded for participants in Cohort A. This information is used as input for organ and whole-body effective dose calculation using Organ Level INternal Dose Assessment/EXponential Modeling (OLINDA/EXM). This will provide the data of whole-body effective dose (millisievert (mSv)/megabecquerels (MBq)), and organ doses.

  • Time to maximum observed concentration (Tmax) (Cohort A)Up to 8 weeks

    Pharmacokinetic (PK) parameters for participants in Cohort A derived from plasma will be calculated using a non-compartmental approach with a log-linear terminal assumption for up to a possible 5 time points. A custom software package or a commercial software package like Phoenix WinNonlin will be used to compute the time it takes for a drug to reach the maximum concentration (Cmax) after administration of a drug that needs to be absorbed.

  • Maximum observed concentration (Cmax) (Cohort A)Up to 8 weeks

    PK parameters for participants in Cohort A derived from plasma will be calculated using a non-compartmental approach with a log-linear terminal assumption for up to a possible 5 time points. A custom software package or a commercial software package like Phoenix WinNonlin will be used to compute the maximum concentration (Cmax) after administration of a drug that needs to be absorbed.

  • Area under the concentration-time curve (AUC) (Cohort A)Up to 8 weeks

    PK parameters for participants in Cohort A derived from plasma will be calculated using a non-compartmental approach with a log-linear terminal assumption for up to a possible 5 time points. A custom software package or a commercial software package like Phoenix WinNonlin will be used to compute the area under the concentration-time curve (AUC) from hour 0 to the last measurable concentration (AUC0-t; min\*unit/mL)

  • AUC extrapolated to infinity (Cohort A)Up to 8 weeks

    PK parameters for participants in Cohort A derived from plasma will be calculated using a non-compartmental approach with a log-linear terminal assumption for up to a possible 5 time points. A custom software package or a commercial software package like Phoenix WinNonlin will be used to compute the AUC extrapolated to infinity (AUC0-∞; min\*unit/mL)

  • Median clearance (Cohort A)Up to 8 weeks

    PK parameters for participants in Cohort A derived from plasma will be calculated using a non-compartmental approach with a log-linear terminal assumption for up to a possible 5 time points. A custom software package or a commercial software package like Phoenix WinNonlin will be used to compute the volume of plasma which is completely cleared of a substance per minute (mL/min).

  • Apparent terminal elimination rate constant (Cohort A)Up to 8 weeks

    PK parameters for participants in Cohort A derived from plasma will be calculated using a non-compartmental approach with a log-linear terminal assumption for up to a possible 5 time points. A custom software package or a commercial software package like Phoenix WinNonlin will be used to compute the apparent terminal elimination rate constant.

  • Apparent terminal elimination half-life (Cohort A)Up to 8 weeks

    PK parameters for participants in Cohort A derived from plasma will be calculated using a non-compartmental approach with a log-linear terminal assumption for up to a possible 5 time points. A custom software package or a commercial software package like Phoenix WinNonlin will be used to compute apparent terminal elimination half-life (t1/2; min).

  • Change in SUVmax (Cohorts B, C, and D)Up to 8 weeks

    For Cohorts B, C and D, descriptive statistics will be used to summarize the change in SUVmax from baseline to 8 weeks at lesion level for participants in Cohorts B \& C.

  • Change in SUVmax/SUVave (Cohorts B, C, and D)Up to 8 weeks

    For Cohorts B, C and D, descriptive statistics will be used to summarize the change in the ratio of SUVmax/SUVave from baseline to 8 weeks at lesion level for participants in Cohorts B \& C.