Phase 1 Study to Evaluate Safety, Effectiveness, and Drug Behavior of EVOLVE104 in Adults With Advanced Urothelial and Squamous Cell Carcinomas

What this Trial Is About

Researchers are evaluating the safety, tolerability, and pharmacokinetics of EVOLVE104 in adults with advanced or metastatic urothelial and squamous cell carcinomas who have progressed after or cannot undergo standard treatments. This first-in-human Phase 1a1b study includes participants with various advanced solid tumors such as bladder, lung, esophageal, tongue, skin, and anogenital squamous cell carcinomas. The study aims to determine safe dosage levels and gather early data on treatment effects and safety. Participants receive EVOLVE104 as an intravenous infusion in a dose-escalation Phase 1a stage followed by a dose-expansion Phase 1b stage, where dosing for expansion cohorts is based on earlier findings. Treatment continues until disease progression, unacceptable side effects, participant or investigator decision, withdrawal of consent, or death. The expected treatment duration averages about 10 months depending on individual progression. During the study, participants will have regular safety and pharmacokinetic assessments including blood tests, tumor imaging by CT or MRI, and biopsies. Researchers will monitor for treatment-related adverse events, dose-limiting toxicities, and drug levels in the body during 28-day cycles. Effectiveness is also evaluated throughout treatment. Participants must agree to use contraception during and for 120 days after treatment. The total participation time aligns with treatment duration and follow-up for safety and efficacy assessments.

A Study Evaluating the Safety, Efficacy, and Pharmacokinetics (PK) of EVOLVE104 in Participants With Advanced Urothelial and Squamous Cell Carcinomas