A Phase 1a/1b Study of LY4052031, an Antibody-Drug Conjugate Targeting Nectin-4, in Participants With Advanced or Metastatic Urothelial Carcinoma or Other Solid Tumors

What this Trial Is About

Researchers are evaluating LY4052031, an antibody-drug conjugate targeting the protein nectin-4 found on certain cancer cells, in participants with advanced or metastatic solid tumors including urothelial carcinoma. This Phase 1a/1b study aims to assess the safety, tolerability, and effectiveness of LY4052031 in these cancers. The study is conducted by Eli Lilly and Company and will last up to approximately four years. The study includes two phases: Phase 1a focuses on dose escalation and optimization to find the recommended Phase 2 dose. LY4052031 is given intravenously in escalating doses during this phase. Phase 1b is a dose-expansion phase that evaluates the safety and antitumor activity of LY4052031 at the optimal dose in different tumor types and treatment histories. Participants receive LY4052031 intravenously throughout the study. Participants will be closely monitored through assessments of tumor response and safety over up to four years. Researchers will measure outcomes such as overall response rate, duration of response, progression-free survival, and overall survival. Pharmacokinetic properties of the drug will also be evaluated during the first treatment cycle. Safety and tolerability will be assessed continuously, with regular visits and evaluations to track effects and disease status.

A Study of LY4052031 in Participants With Advanced or Metastatic Urothelial Cancer or Other Solid Tumors