64Cu-GRIP B in Patients With Advanced Malignancies

Introduction

• Org Study ID: 23921
• NTC ID: NCT05888532
• Lead Sponsor Name: University of California, San Francisco
• Status: RECRUITING

Conditions

• Chromophobe Renal Cell Carcinoma
• Clear Cell Renal Cell Carcinoma
• Collecting Duct Renal Cell Carcinoma
• Papillary Renal Cell Carcinoma
• Renal Medullary Carcinoma
• Translocation/TFE Renal Cell Carcinoma
• Unclassified Renal Cell Carcinoma

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.

Eligibility Criteria

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 60 mL/min
* Total bilirubin