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

Part of paid clinical trials in Duarte, California.

Sponsor
Generate Biomedicines
Study ID
NCT07484022
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Advanced Urothelial Cancer
  • Metastatic Urothelial Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • GB-4362 — DRUG
    GB-4362 is an investigational monoclonal antibody
  • enfortumab vedotin (EV) — DRUG
    Enfortumab vedotin is an antibody-drug conjugate targeting Nectin-4 that delivers the cytotoxic payload monomethyl auristatin E (MMAE).
  • Pembrolizumab — DRUG
    Pembrolizumab is a programmed death-1 (PD-1) immune checkpoint inhibitor administered as standard-of-care therapy for advanced urothelial cancer.

Study Details

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.

Key Dates

Start date
Jun 30, 2026
Status verified
Jun 2026
Primary completion
Jun 30, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
37 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: GB-4362 in Combination With Enfortumab Vedotin and Pembrolizumab

Primary Outcome Measure

Incidence of AEs and SAEs [ Time Frame: From first dose of GB-4362 through 18 weeks after the last dose of GB-4362 (or prior to initiation of subsequent anti-cancer therapy, whichever occurs first). ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
City of HopeDuarteCalifornia91010
Study Info Study Info
[email protected]
800-555-5555
Orlando HealthOrlandoFlorida32806
Janice Porter M Clinical Research Screening & Eligibility Manager
[email protected]
321-841-7246
Southeastern Regional Medical CenterTuckerGeorgia30084
Study Info
[email protected]
800-555-5555
Midwestern Regional Medical CenterZionIllinois60099
Study Info
[email protected]
800-555-5555
Start New York, LLCLake SuccessNew York11042
Camilita Goberdhan
[email protected]
347-476-1959
MSKNew YorkNew York10065
Study Info
[email protected]
800-555-5555
The University of VirginaCharlottesvilleVirginia22908
Clinical Trials Navigator
[email protected]
434-982-0539

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City of Hope· Duarte, CAOrlando Health· Orlando, FLSoutheastern Regional Medical Center· Tucker, GAMidwestern Regional Medical Center· Zion, ILStart New York, LLC· Lake Success, NYMSK· New York, NY

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