NCT05888532 64Cu-GRIP B in Patients With Advanced Malignancies
| NCT ID | NCT05888532 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Rahul Aggarwal |
| Condition | Prostate Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 91 participants |
| Start Date | 2023-05-25 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 91 participants in total. It began in 2023-05-25 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 \<= 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.
Contact & Investigator
Rahul Aggarwal, MD
PRINCIPAL INVESTIGATOR
University of California, San Francisco
Frequently Asked Questions
Who can join the NCT05888532 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05888532 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05888532 currently recruiting?
Yes, NCT05888532 is actively recruiting participants. Contact the research team at jessie.huang2@ucsf.edu for enrollment information.
Where is the NCT05888532 trial being conducted?
This trial is being conducted at San Francisco, United States.
Who is sponsoring the NCT05888532 clinical trial?
NCT05888532 is sponsored by Rahul Aggarwal. The principal investigator is Rahul Aggarwal, MD at University of California, San Francisco. The trial plans to enroll 91 participants.
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