Clinical Trials | 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 University of Virginia Comprehensive Cancer Center seeks participants ages 18 and over with advanced or metastatic urothelial cancer for a research study. The purpose of the study is to assess the safety and tolerability of the investigational drug GB-4362 when administered in combination with standard of care enfortumab vedotin (EV) and pembrolizumab in patients with advanced urothelial cancer. EV can cause peripheral neuropathy with is damage to nerves resulting in numbness, tingling, and pain. Peripheral neuropathy is one of the most common reasons for patients with advanced urothelial cancer to have to reduce the dose or stop EV. GB-4362 might be able to reduce the risk of developing peripheral neuropathy in patients treated with EV. This is the first study to test GB-4362 in people and is making sure that adding GB-4362 to standard of care EV and pembrolizumab will be safe and well-tolerated. Participants in the study will receive standard therapy (EV and pembrolizumab) as part of your cancer treatment, with GB-4362 added to see how it affects safety and drug levels. This study includes 2 parts: Dose Escalation, and Dose Expansion. In Dose Escalation, GB-4362 will be administered in Cycles 2 and 3 of EV and pembrolizumab on days when EV is administered. The dose of GB-4362 will increase over time in order to find the safest dose of GB-4362. In Dose Expansion, GB-4362 will be administered when EV and pembrolizumab are administered starting in Cycle 2 and thereafte4r on days when EV is administered at the safest dose determined during the Dose Escalation part of the study. The total time in the study will depend on which part of the study you join. You will be told by your study doctor whether you are participating in the Dose Escalation or the Dose Expansion part of the study, based on when you enroll in the study. The End of Treatment visit should be approximately 21 days after the last dose of GB-4362. A Safety Follow-up visit should be completed 18 weeks after the last dose of GB-4362 or before starting subsequent anti-cancer therapy, whichever occurs first.