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64Cu-GRIP B PET Imaging for Genitourinary Cancer

Phase 1 & 2

Recruiting

Led By Rahul Aggarwal, MD

Research Sponsored by Rahul Aggarwal

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 18 years or older at the time of study entry

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

Study Summary

This trial tests a new imaging tool to detect activated immune cells in tumors, which could help identify tumors that will respond to immunotherapy treatments. #MedicalResearch

Who is the study for?

This trial is for adults with advanced genitourinary cancers, such as kidney and urethral cancer. Participants must be over 18, not pregnant or breastfeeding, willing to use contraception, and have a good performance status (able to carry out daily activities). They should have adequate organ function and specific types of metastatic cancer confirmed by tests.Check my eligibility

What is being tested?

The study is testing a new imaging technique using Copper-64 labeled Granzyme B (64Cu-GRIP B) with PET scans in patients with advanced genitourinary malignancies. It aims to identify tumors that may respond well to immunotherapy based on the presence of certain immune cells within the tumor.See study design

What are the potential side effects?

As this is an imaging study primarily focused on detecting granzyme B in tumors using PET scans, direct side effects from the tracer are not extensively detailed but could include reactions at the injection site or allergic responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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My kidney or urinary cancer has spread and this is confirmed by tests.

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My kidney, liver, and blood counts are within the required ranges.

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I am fully active or restricted in physically strenuous activity but can do light work.

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My cancer has spread and this was confirmed by tests.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

AUC extrapolated to infinity (Cohort A)

Apparent terminal elimination half-life (Cohort A)

Apparent terminal elimination rate constant (Cohort A)

+8 more

Secondary outcome measures

Association of baseline uptake with object response (ORR) (Cohorts B, C and D)

Association of baseline uptake with progression-free survival (PFS) (Cohorts B, C and D)

Association of baseline uptake with reported PSA50 response (Cohort C)

+6 more

Trial Design

4Treatment groups

Experimental Treatment

Group I: Cohort D: 64Cu-GRIP B, Advanced malignanciesExperimental Treatment2 Interventions

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.

Group II: Cohort C: 64Cu-GRIP B, mCRPC participantsExperimental Treatment2 Interventions

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.

Group III: Cohort B: 64Cu-GRIP B, RCC and UC participantsExperimental Treatment2 Interventions

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.

Group IV: Cohort A: 64Cu-GRIP B, Metastatic GU malignanciesExperimental Treatment2 Interventions

Participants with metastatic GU malignancy (renal, urothelial, or prostate) (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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Positron Emission Tomography (PET)

2018

Completed Phase 4

~1390

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Rahul AggarwalLead Sponsor

11 Previous Clinical Trials

429 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,672 Previous Clinical Trials

40,926,350 Total Patients Enrolled

20 Trials studying Urethral Cancer

2,080 Patients Enrolled for Urethral Cancer

U.S. Army Medical Research Acquisition ActivityFED

20 Previous Clinical Trials

1,900 Total Patients Enrolled

Media Library

Cohort A: 64Cu-GRIP B, Metastatic GU malignancies Clinical Trial Eligibility Overview. Trial Name: NCT05888532 — Phase 1 & 2

Urethral Cancer Research Study Groups: Cohort A: 64Cu-GRIP B, Metastatic GU malignancies, Cohort B: 64Cu-GRIP B, RCC and UC participants, Cohort C: 64Cu-GRIP B, mCRPC participants, Cohort D: 64Cu-GRIP B, Advanced malignancies

Urethral Cancer Clinical Trial 2023: Cohort A: 64Cu-GRIP B, Metastatic GU malignancies Highlights & Side Effects. Trial Name: NCT05888532 — Phase 1 & 2

Cohort A: 64Cu-GRIP B, Metastatic GU malignancies 2023 Treatment Timeline for Medical Study. Trial Name: NCT05888532 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are participants still being accepted for this trial?

"The trial detailed on clinicaltrials.gov is no longer gathering participants, despite its initial posting date of July 1st 2023 and latest edit on May 24th 2023. However, there are 986 other similar studies actively seeking patients at this moment in time."

Answered by AI

What effects are researchers hoping to observe from this experiment?

"This trial's primary goal is to analyse the percentage of injected activity over a period not exceeding 8 weeks (Cohort A). Additionally, it will attempt to discern further associations such as that between baseline uptake and objective response (ORR) using RECIST 1.1/PCWG3 criteria for Cohorts B and C; progression-free survival with SUVmax dichotomized above or below the median PFS in cohort patients; and finally, SUVmax compared against reported PSA50 responses through linear mixed models."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

64Cu-GRIP B in Patients With Advanced Malignancies

Rahul Aggarwal 2023. "64Cu-GRIP B in Patients With Advanced Malignancies". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05888532.