GB-4362 + Enfortumab Vedotin + Pembrolizumab for Bladder Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Are You a Good Fit for This Trial?
Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Dose Escalation
Multiple dose levels of GB-4362 are evaluated to assess safety, identify dose-limiting toxicities, and characterize pharmacokinetics and pharmacodynamics.
Dose Expansion
Additional participants are enrolled at the selected GB-4362 dose level to further evaluate safety, pharmacokinetics, and pharmacodynamics.
Follow-up
Participants are monitored for safety and effectiveness after treatment, including evaluation of peripheral neuropathy and anti-tumor activity.
What Are the Treatments Tested in This Trial?
Interventions
- Enfortumab Vedotin
- GB-4362
- Pembrolizumab
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Find a Clinic Near You
Who Is Running the Clinical Trial?
Generate Biomedicines
Lead Sponsor
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