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Study of GB-4362 With Enfortumab Vedotin and Pembrolizumab for Advanced Urothelial Cancer

StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial sites expanded: 7 → 10 locationsv5
  2. Start date: Apr 2026 to Jun 2026 Study sites: 6 to 7v4 Show 1 more changeShow less
    • Study sites: 6 to 7
  3. Trial sites expanded: 2 → 6 locationsv3
  4. Recruitment opened Study sites: 1 to 2 · Start date: Mar 2026 to Apr 2026v2 Show 2 more changesShow less
    • Study sites: 1 to 2
    • Start date: Mar 2026 to Apr 2026
  5. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
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.
Trial Details
NCT Number NCT07484022
Lead Sponsor Generate Biomedicines
Conditions Advanced Urothelial Cancer, Metastatic Urothelial Carcinoma
Enrollment 37 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov