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64Cu-GRIP B in Patients With Advanced Malignancies

NCT05888532 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 91

Last updated 2026-03-17

No results posted yet for this study

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

Interventions

DRUG

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

Given IV prior to imaging

PROCEDURE

Positron Emission Tomography (PET)

Imaging procedure

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • U.S. Army Medical Research Acquisition Activity

    collaborator FED

  • Rahul Aggarwal

    lead OTHER

Principal Investigators

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

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-25
Primary Completion
2026-12-31
Completion
2027-01-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05888532 on ClinicalTrials.gov