64Cu-GRIP B in Patients With Advanced Malignancies

Launched by RAHUL AGGARWAL · May 24, 2023

Keywords

ClinConnect Summary

**Clinical Trial Summary: 64Cu-GRIP B in Patients With Advanced Cancers**

This clinical trial is studying a new imaging method using a special substance called 64Cu-GRIP B to see if it can help doctors detect a protein called granzyme B (GrB) in patients with advanced cancers, such as prostate, kidney, and urethral cancers. Granzyme B is produced by the immune system and may indicate how well a tumor responds to certain treatments. By using a type of imaging called PET scans, researchers hope to find out if this method can safely identify tumors that are more likely to respond to immunotherapy, which helps the body’s immune system fight cancer.

To participate in this trial, patients need to be at least 18 years old and have specific types of cancer that have spread to other parts of the body. They should also be planning to receive a treatment called an immune checkpoint inhibitor. Participants will undergo a few procedures, including imaging scans and possibly biopsies (taking small tissue samples from tumors). The trial is currently looking for volunteers, and those interested should be in good health overall, not pregnant or breastfeeding, and able to follow the study guidelines. This research may help improve future treatments for cancer patients by providing valuable information about how their tumors respond to therapies.

Gender

ALL

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.