NCT05888532RecruitingPhase 1/2
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
Source: ClinicalTrials.gov · Last updated 17 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 91 (estimated)
- First submitted
- 24 May 2023
- Start date
- 25 May 2023
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Rahul Aggarwal
- Diseases
- Prostate cancer, Kidney cancer
- NCT number
- NCT05888532
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 91
- From 25 May 2023 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Any condition that, in the opinion of the Principal Investigator, would impair the patient's ability to comply with study procedures.
Age
- Patients who because of age, general medical or psychiatric condition, or physiologic status cannot give valid informed consent.
Other
- Is currently pregnant or breastfeeding.
Who the study is looking for
- 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
- Planned treatment with immune checkpoint inhibitor (Cohorts B and C only)
- Willing to undergo paired tumor biopsies and has safely accessible bone or soft tissue lesion (Cohorts B and C only)
- The subject is able and willing to comply with study procedures and provide signed and dated informed consent.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
- Age 18 years or older at the time of study entry.
- 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
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of California San Francisco Coordinator of this site? Confirm its status | San Francisco | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.