Phase 1 Trial of GB-4362 with Enfortumab Vedotin and Pembrolizumab for Advanced or Metastatic Urothelial Cancer Evaluating Safety and Drug Effects

What this Trial Is About

Researchers are evaluating the safety and tolerability of an investigational drug called GB-4362 when given alongside enfortumab vedotin and pembrolizumab in adults with advanced or metastatic urothelial cancer. This Phase 1, open-label, multicenter study aims to assess GB-4362s ability to bind and neutralize free monomethyl auristatin E MMAE, a chemotherapy component from enfortumab vedotin that can cause side effects like peripheral neuropathy. The study consists of two parts dose escalation and dose expansion. During dose escalation, multiple dose levels of GB-4362 will be tested in combination with standard doses of enfortumab vedotin and pembrolizumab to assess safety, identify toxicities, and study how the drug behaves in the body. After selecting a dose, the dose expansion phase will further evaluate safety and drug effects, including monitoring peripheral neuropathy and any dose changes to enfortumab vedotin. Participants will receive GB-4362 together with enfortumab vedotin and pembrolizumab, with safety and drug activity monitored from the first dose through 18 weeks after the last dose or until starting another cancer therapy. Researchers will conduct assessments including adverse event tracking, pharmacokinetics, pharmacodynamics, and immunogenicity. The study focuses on understanding side effects and drug behavior during and after treatment, with participant involvement lasting several months.

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