RECRUITING

64Cu-GRIP B in Patients With Advanced Malignancies

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Conditions

Prostate CancerRenal CancerUrethral CancerAdvanced Solid TumorMetastatic Castration-resistant Prostate CancerSolid Tumor, AdultImaging StudyRadiotracerGranzyme B

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A First-in-Human, Phase I/II PET Imaging Study of 64Cu-GRIP B, a Radiotracer Targeting Granzyme B, in Patients With Advanced Malignancies

Quick Facts

Study Start:2023-05-25
Study Completion:2027-01-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05888532

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Disease characteristics by cohort, as defined by:
  2. * Histologically-confirmed metastatic solid tumor malignancy (3 Male, 3 Female)
  3. * Locally advanced or metastatic disease on conventional imaging
  4. * Histologically-confirmed metastatic renal cell carcinoma (any histologic sub-type) or urothelial carcinoma
  5. * Locally advanced or metastatic disease on conventional imaging
  6. * Histologically-confirmed prostate adenocarcinoma
  7. * Metastatic castration resistant prostate cancer by Prostate Cancer Clinical Trials Working Group 3 (PCWG3) criteria
  8. 2. Planned treatment with immune checkpoint inhibitor (Cohorts B and C only)
  9. 3. Willing to undergo paired tumor biopsies and has safely accessible bone or soft tissue lesion (Cohorts B and C only)
  10. 4. The subject is able and willing to comply with study procedures and provide signed and dated informed consent.
  11. 5. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
  12. 6. Age 18 years or older at the time of study entry.
  13. 7. Adequate organ function, as defined by:
  14. * Serum creatinine \<= 1.5 x upper limit of normal (ULN) or estimated creatinine clearance \> 60 mL/min
  15. * Total bilirubin \<= 1.5 x ULN (\< 3 x ULN in patients with documented or suspected Gilbert's).
  16. * Hemoglobin \>= 8.0 g/dL
  17. * Platelet count \>= 75,000/microliter
  18. * Absolute neutrophil count ≥ 1000/microliter
  19. 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.
  1. 1. Patients who because of age, general medical or psychiatric condition, or physiologic status cannot give valid informed consent.
  2. 2. Any condition that, in the opinion of the Principal Investigator, would impair the patient's ability to comply with study procedures.
  3. 3. Is currently pregnant or breastfeeding.

Contacts and Locations

Study Contact

Khadija Siddiqua
CONTACT
(310) 794-7329
khadija.siddiqua@ucsf.edu

Principal Investigator

Rahul Aggarwal, MD
PRINCIPAL_INVESTIGATOR
University of California, San Francisco

Study Locations (Sites)

University of California, San Francisco
San Francisco, California, 94143
United States

Collaborators and Investigators

Sponsor: Rahul Aggarwal

  • Rahul Aggarwal, MD, PRINCIPAL_INVESTIGATOR, University of California, San Francisco

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-05-25
Study Completion Date2027-01-31

Study Record Updates

Study Start Date2023-05-25
Study Completion Date2027-01-31

Terms related to this study

Keywords Provided by Researchers

  • Imaging Study
  • Radiotracer
  • Granzyme B

Additional Relevant MeSH Terms

  • Prostate Cancer
  • Renal Cancer
  • Urethral Cancer
  • Advanced Solid Tumor
  • Metastatic Castration-resistant Prostate Cancer
  • Solid Tumor, Adult