Actively Recruiting
Study of GB-4362 With Enfortumab Vedotin and Pembrolizumab for Advanced Urothelial Cancer
Led by Generate Biomedicines · Updated on 2026-04-07
37
Participants Needed
2
Research Sites
87 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study of GB-4362 With Enfortumab Vedotin and Pembrolizumab for Advanced Urothelial Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Planned to receive standard-of-care treatment with enfortumab vedotin (EV) in combination with pembrolizumab for locally advanced or metastatic urothelial cancer
- Age 18 years or older
- ECOG Performance Status score of 0 or 1 (ECOG 2 excluded in Dose Escalation but allowed in Dose Expansion)
- Weight 50 kg or more at screening
- Life expectancy of 3 months or more, as determined by the investigator
- Able to provide written informed consent and understand the study purpose and risks
- Willing and able to follow all study assessments and protocol requirements
You will not qualify if you...
- Previously received enfortumab vedotin or other MMAE-based antibody-drug conjugates
- Received chemotherapy, biologics, or investigational anti-cancer treatments within 4 weeks before the first dose of EV/pembrolizumab
- Uncontrolled diabetes
- Active central nervous system (CNS) metastases, unless clinically stable for at least 4 weeks and meeting specific steroid and disease criteria
- Ongoing significant side effects from prior treatments that have not resolved to Grade 1 or baseline
- History of severe (Grade 3 or higher) allergic or infusion-related reactions to any monoclonal antibody
- Other medical conditions that may impair ability to receive or tolerate treatment and follow-up, as judged by the investigator
- Known psychiatric or substance abuse disorders interfering with study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Orlando Health
Orlando, Florida, United States, 32806
Actively Recruiting
2
Start New York, LLC
Lake Success, New York, United States, 11042
Actively Recruiting
Research Team
S
Study Contact
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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