64Cu-GRIP B in Patients With Advanced Malignancies
Recruiting · NCT05888532 · Interventional (participants receive a specific treatment) · Lead sponsor: Rahul Aggarwal
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- 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.
Exclusion criteria
- Patients who because of age, general medical or psychiatric condition, or physiologic status cannot give valid informed consent.
- Any condition that, in the opinion of the Principal Investigator, would impair the patient's ability to comply with study procedures.
- Is currently pregnant or breastfeeding.
Where it is running
1 location listed across 1 US state.
- University of California, San Francisco - San Francisco, California, United States