A Phase 1, Open-Label Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of GB-4362 Administered With Enfortumab Vedotin and Pembrolizumab in Participants With Advanced Urothelial Cancer

Study Identifier:
GB-4362-101
CT.gov Identifier:
NCT07484022
EudraCT Identifier:
N/A
EU Trial (CTIS) Number:
N/A
Study Contact Information:
(210) 593-5651 or [email protected]
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Study Summary

The purpose of this study is to evaluate the safety and tolerability of an investigational drug called GB-4362 when it is given together with enfortumab vedotin and pembrolizumab in adults with advanced or metastatic urothelial cancer. GB-4362 is a monoclonal antibody designed to bind and neutralize free monomethyl auristatin E (MMAE), a chemotherapy payload released from enfortumab vedotin that is associated with side effects such as peripheral neuropathy.

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
  • Bladder
  • Renal
    • Phase
    The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
    I
    Sex
    Female & Male
    Age
    18+ years
    Study Drug
  • Drug: EXPERIMENTAL: GB-4362 in Combination With Enfortumab Vedotin and Pembrolizumab
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  • Drug: Drug: enfortumab vedotin (EV)
  • Drug: Enfortumab vedotin is an antibody-drug conjugate targeting Nectin-4 that delivers the cytotoxic payload monomethyl auristatin E (MMAE).
  • Drug: Drug: GB-4362
  • Drug: GB-4362 is an investigational monoclonal antibody
  • Drug: Drug: Pembrolizumab
  • Drug: Pembrolizumab is a programmed death-1 (PD-1) immune checkpoint inhibitor administered as standard-of-care therapy for advanced urothelial cancer.
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Recruiting

    Requirements information
    Inclusion criteria
    • Inclusion Criteria
    • * Planned to receive standard-of-care treatment with enfortumab vedotin (EV) (starting dose 1.25 mg/kg) in combination with pembrolizumab for locally advanced or metastatic urothelial cancer.
    • * Age ≥18 years.
    • * ECOG Performance Status score of 0 or 1 (ECOG 2 excluded in Dose Escalation but allowed in Dose Expansion).
    • * Weight ≥50 kg at screening.
    • * Life expectancy ≥3 months, as determined by the investigator.
    • * Participants must provide written informed consent before any study-related activities are carried out and must be able to understand the nature and purpose of the study, including potential risks and adverse effects.
    • * Willing and able to comply with all study assessments and adhere to the protocol schedule and restrictions.
    Exclusion criteria
    • Previously received enfortumab vedotin (EV) or other MMAE-based antibody-drug conjugates (ADCs).
    • * Received anti-cancer treatment with chemotherapy, biologics, or investigational agents within 4 weeks before the first dose of EV/pembrolizumab.
    • * Uncontrolled diabetes.
    • * Active CNS metastases. Participants with treated CNS metastases are permitted if all of the following criteria are met:
    • * CNS metastases have been clinically stable for at least 4 weeks prior to screening and baseline scans show no evidence of new or enlarged metastasis.
    • * The participant is on a stable dose of ≤10 mg/day of prednisone or equivalent for at least 2 weeks (if requiring steroid treatment).
    • * The participant does not have leptomeningeal disease.
    • * Ongoing clinically significant toxicity associated with prior treatment (including radiotherapy or surgery) that has not resolved to Grade ≤1 or returned to baseline.
    • * History of a severe (Grade ≥3) allergic or infusion-related reaction to any monoclonal antibody.
    • * Another underlying medical condition that, in the opinion of the investigator, would impair the ability of the participant to receive or tolerate the planned treatment and follow-up.
    • * Known psychiatric or substance abuse disorders that would interfere with cooperating with study requirements

    Clinical Study Information for Healthcare Providers

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    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START New York (Long Island)
    Lake Success, NY, United States, 11042
    Investigator
    Geraldine O'Sullivan Coyne
    Status
    Will Be Recruiting
    Condition(s) Treated at Site
    Bladder
    Renal