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64Cu-GRIP B in Patients With Advanced Malignancies

StatusRecruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Minor Site contact updatedv7
  2. Minor Re-verified, no change to tracked fieldsv6
  3. Minor Study description shortened, about 4 wordsv5
  4. Notable Primary endpoints revised (11)v4 Show 6 more changesShow less
    • Enrollment target: 61 to 91
    • Secondary endpoints revised (9)
    • Study description expanded, about 74 words
    • Site contact updated
    • Study arms: 3 to 4
    • Study title shortened, about 1 word
  5. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jul 1, 2023 to May 25, 2023
    • Site details revised
    v3
  6. Minor Re-verified, no change to tracked fieldsv2
  7. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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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.
Trial Details
NCT Number NCT05888532
Lead Sponsor Rahul Aggarwal
Collaborators: National Cancer Institute (NCI), U.S. Army Medical Research Acquisition Activity
Conditions
(from sponsor)
Prostate Cancer, Renal Cancer, Urethral Cancer, Advanced Solid Tumor, Metastatic Castration-resistant Prostate Cancer, Solid Tumor, Adult
Related terms Kidney Neoplasms, Lipodystrophy, Congenital Generalized, Prostatic Neoplasms, Urethral Neoplasms
Enrollment 91 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov