GB-4362 Added to Enfortumab Vedotin and Pembrolizumab for Advanced Bladder-Type Cancer
Tests GB-4362 with two cancer drugs in adults with advanced urothelial cancer.
Plain-language title generated from the registry record
Registry title: Study of GB-4362 With Enfortumab Vedotin and Pembrolizumab for Advanced Urothelial Cancer
Key facts
- Where
- Charlottesville, Duarte, Houston, Irvine, Lake Success, New Brunswick, New York, Orlando, Tucker, and Zion, United StatesSee the 10 sites
- Phase
- Phase 1
Where in United States
- The University of VirginaCharlottesville, United StatesTaking people
- City of HopeDuarte, United StatesTaking people
- MDACCHouston, United StatesTaking people
- COH LennarIrvine, United StatesTaking people
- Start New York, LLCLake Success, United StatesTaking people
- RutgersNew Brunswick, United StatesTaking people
- MSKNew York, United StatesTaking people
- Orlando HealthOrlando, United StatesTaking people
- COH AtlantaTucker, United StatesTaking people
- COH ChicagoZion, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Generate Biomedicines
- Trial code
- NCT07484022
- Record updated
- 13 October 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: Planned to initiate, or (for dose escalation only) already receiving, 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); 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: 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); Uncontrolled diabetes; The participant does not have leptomeningeal disease; 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; Active CNS metastases. Participants with treated CNS metastases are permitted if all of the following criteria are met:; No Grade > 1 sensory or motor peripheral neuropathy.