Recruiting
Phase 1
Phase 2

64Cu-GRIP B

Sponsor:

Rahul Aggarwal

Code:

NCT05888532

Conditions

Prostate Cancer

Renal Cancer

Urethral Cancer

Advanced Solid Tumor

Metastatic Castration-resistant Prostate Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Copper-64 labeled Granzyme B (64Cu-GRIP B)

Positron Emission Tomography (PET)

Study Details

Brief 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.

Conditions

Prostate Cancer

Renal Cancer

Urethral Cancer

Advanced Solid Tumor

Metastatic Castration-resistant Prostate Cancer

Study ID

NCT05888532

Start date

May 25, 2023

Status verified date

Mar, 2026

Completion date

Jan 31, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Disease characteristics by cohort, as defined by:

Cohort A:
  • Histologically-confirmed metastatic solid tumor malignancy (3 Male, 3 Female)
  • Locally advanced or metastatic disease on conventional imaging

Cohort B:
  • Histologically-confirmed metastatic renal cell carcinoma (any histologic sub-type) or urothelial carcinoma
  • Locally advanced or metastatic disease on conventional imaging

Cohort C:
  • 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.

Exclusion Criteria:

1. Patients who because of age, general medical or psychiatric condition, or physiologic status cannot give valid informed consent.
2. Any condition that, in the opinion of the Principal Investigator, would impair the patient's ability to comply with study procedures.
3. Is currently pregnant or breastfeeding.

Study Design

Enrollment

91 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Cohort A: 64Cu-GRIP B, Solid Tumor Malignancy participants

Participants with solid tumor malignancies (3 males, 3 females), dosimetry calculation will be performed by obtaining whole body (vertex to thighs) PET images up to five time points from 0.5 to 24 hours post 64Cu-GRIP B injections. An additional intravenous line will be placed in the contra-lateral arm to collect blood for this group.

experimental: Cohort B: 64Cu-GRIP B, RCC and UC participants

Participants with renal cell and urothelial carcinoma will have longitudinal imaging performed prior to treatment outside of this study with anti-programmed death-1 (PD-1)/anti-PD-1 ligand 1 (PD-L1) blockade (with or without concomitant anti-CTLA4 treatment), after 8 weeks of checkpoint blockade, and again at the time of disease progression by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.

experimental: Cohort C: 64Cu-GRIP B, mCRPC participants

Participants with metastatic castration resistant prostate cancer (mCRPC)) will have longitudinal imaging performed prior to treatment outside of this study, 8 weeks following initiation of treatment outside of this study, and at the time of disease progression by Prostate Cancer Working Group 3 (PCWG3) criteria.

experimental: Cohort D: 64Cu-GRIP B, Advanced malignancies

participants with solid tumor malignancies will have longitudinal imaging performed prior to treatment outside of this study, 8 weeks following initiation of treatment, and the opportunity to have an optional scan at the time of progression.

Interventions

Copper-64 labeled Granzyme B (64Cu-GRIP B)

Given IV prior to imaging

Positron Emission Tomography (PET)

Imaging procedure

Primary outcome measure

  • Frequency of treatment-emergent adverse events (Cohort A) [ Time Frame: Up to 8 weeks ]
  • Percent of injected activity (Cohort A) [ Time Frame: Up to 8 weeks ]
  • Time to maximum observed concentration (Tmax) (Cohort A) [ Time Frame: Up to 8 weeks ]
  • Maximum observed concentration (Cmax) (Cohort A) [ Time Frame: Up to 8 weeks ]
  • Area under the concentration-time curve (AUC) (Cohort A) [ Time Frame: Up to 8 weeks ]
  • AUC extrapolated to infinity (Cohort A) [ Time Frame: Up to 8 weeks ]
  • Median clearance (Cohort A) [ Time Frame: Up to 8 weeks ]
  • Apparent terminal elimination rate constant (Cohort A) [ Time Frame: Up to 8 weeks ]
  • Apparent terminal elimination half-life (Cohort A) [ Time Frame: Up to 8 weeks ]
  • Change in SUVmax (Cohorts B, C, and D) [ Time Frame: Up to 8 weeks ]
  • Change in SUVmax/SUVave (Cohorts B, C, and D) [ Time Frame: Up to 8 weeks ]

Central Contacts and Locations

Central contacts

Jessie Huang

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

Locations

University of California, San Francisco

Recruiting

San Francisco, California, United States, 94143

Contacts

Jessie Huang

jessie.huang2@ucsf.edu

877-827-3222cancertrials@ucsf.edu

Principal Investigator:

Rahul Aggarwal, MD

More Information

Sponsor

Rahul Aggarwal

Last update posted

Mar 17, 2026

Last verified

Mar, 2026

Keywords

  • Imaging Study
  • Radiotracer
  • Granzyme B

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Rahul Aggarwal on 2026-03-17.