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GB-4362

Phase 1

Advanced Urothelial Cancer | Small molecule | Oncology |Generate Biomedicines, Inc.|Last Updated: Jun 3, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment37
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07484022Study of GB-4362 With Enfortumab Vedotin and Pembrolizumab for Advanced Urothelial CancerPHASE1 RECRUITING 37 — — Jun 1, 2026Dec 1, 2027Jun 3, 20267 United States
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Study Endpoints
Primary Endpoints
Incidence of AEs and SAEs
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).
Secondary Endpoints
Pharmacokinetics of GB-4362
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).
Reduction of Free MMAE Levels
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).
Immunogenicity of GB-4362
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).
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
GB-4362 in Combination With Enfortumab Vedotin and PembrolizumabEXPERIMENTAL -
Interventions
NameTypeDescription
GB-4362DRUGGB-4362 is an investigational monoclonal antibody
enfortumab vedotin (EV)DRUGEnfortumab vedotin is an antibody-drug conjugate targeting Nectin-4 that delivers the cytotoxic payload monomethyl auristatin E (MMAE).
PembrolizumabDRUGPembrolizumab is a programmed death-1 (PD-1) immune checkpoint inhibitor administered as standard-of-care therapy for advanced urothelial cancer.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites7

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 Esca...

Countries:United States
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Recent Changes (Last 90 Days)
LOWJun 3, 2026NCT07484022startDate: changed
LOWJun 3, 2026NCT07484022startDate: changed
LOWMay 26, 2026NCT07484022Status: NOT_YET_RECRUITING → RECRUITING
LOWMay 24, 2026NCT07484022studyFirstPostDate: changed