Status:

RECRUITING

64Cu-GRIP B in Patients With Advanced Malignancies

Lead Sponsor:

Rahul Aggarwal

Collaborating Sponsors:

National Cancer Institute (NCI)

U.S. Army Medical Research Acquisition Activity

Conditions:

Prostate Cancer

Renal Cancer

Eligibility:

All Genders

18+ years

Phase:

PHASE1

PHASE2

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 positr...

Detailed Description

PRIMARY OBJECTIVES: I. To determine the safety, dosimetry, and pharmacokinetics of 64Cu-GRIP B PET in patients with solid tumor malignancy (3 males, 3 females). (Cohort A) II. To determine the mean p...

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.

Key Trial Info

Start Date :

May 25 2023

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

January 31 2027

Estimated Enrollment :

91 Patients enrolled

Trial Details

Trial ID

NCT05888532

Start Date

May 25 2023

End Date

January 31 2027

Last Update

March 17 2026

Active Locations (1)

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Page 1 of 1 (1 locations)

1

University of California, San Francisco

San Francisco, California, United States, 94143

64Cu-GRIP B in Patients With Advanced Malignancies | DecenTrialz