RecruitingPhase 1Phase 2NCT05888532

64Cu-GRIP B in Patients With Advanced Malignancies

A First-in-Human, Phase I/II PET Imaging Study of 64Cu-GRIP B, a Radiotracer Targeting Granzyme B, in Patients With Advanced Malignancies


Sponsor

Rahul Aggarwal

Enrollment

91 participants

Start Date

May 25, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new PET imaging agent called 64Cu-GRIP B to see how well it can visualize cancer in people with advanced solid tumors, kidney cancer, urothelial cancer, or prostate cancer — with the goal of better predicting who will respond to immunotherapy. **You may be eligible if...** - You have a confirmed advanced solid tumor (Cohort A), metastatic kidney or bladder cancer (Cohort B), or metastatic castration-resistant prostate cancer (Cohort C) - Your disease is locally advanced or has spread to other parts of the body - You are planned to receive immune checkpoint inhibitor therapy (Cohorts B and C) - You have a tumor that can be safely biopsied **You may NOT be eligible if...** - You are unable to safely undergo a tumor biopsy - You have active autoimmune disease - You have uncontrolled infections or serious organ dysfunction - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

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

Given IV prior to imaging

PROCEDUREPositron Emission Tomography (PET)

Imaging procedure


Locations(1)

University of California, San Francisco

San Francisco, California, United States

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NCT05888532


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