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New imaging agent could reveal which cancers respond to immunotherapy

NCT ID NCT05888532

Diagnosis Sponsor: Rahul Aggarwal Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase I/II trial tests a radioactive tracer called 64Cu-GRIP B, which targets granzyme B—a substance released by immune cells. By using PET scans, researchers hope to see immune activity in tumors and predict whether immunotherapy will work. The study involves about 91 adults with advanced genitourinary cancers like prostate, kidney, or bladder cancer. The main goals are to check safety and see if the tracer can measure immune responses over time.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
64Cu-GRIP B (a radioactive tracer that targets granzyme B, an immune cell marker)
What this could lead to
If successful, this imaging method could help doctors see which tumors are responding to immunotherapy early on, guiding treatment decisions.
What could go wrong
This is an early-phase trial focused on safety and imaging, not treatment. The tracer may not reliably predict responses, and results may not apply to all cancers.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 91 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2023

Expected to finish

Jan 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

castration-resistant prostate carcinoma kidney cancer Lipodystrophy, Congenital Generalized metastatic malignant neoplasm metastatic prostate carcinoma prostate cancer renal carcinoma renal cell carcinoma urethra cancer Urethral Neoplasms urothelial carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Advanced solid tumor Metastatic castration resistant prostate cancer Prostate cancer Renal cancer Solid tumor, adult Urethral cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    1 site. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • University of California, San Francisco

    RECRUITING

    San Francisco, California, 94143, United States

    Contact Email: •••••@•••••

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