A First-in-Human, Phase 1a/1b Trial to Assess the Safety, Tolerability and Preliminary Efficacy of LY4170156, an Antibody-Drug Conjugate Targeting Folate Receptor Alpha-Expressing Tumor Cells, in Participants With Selected Advanced Solid Tumors

What this Trial Is About

Researchers are evaluating the safety, tolerability, and preliminary effectiveness of LY4170156, a drug targeting folate receptor alpha-expressing tumor cells, in participants with advanced solid tumors. The study focuses on several types of cancers including ovarian, endometrial, cervical, non-small cell lung, triple negative breast, pancreatic, and colorectal cancers. This research is a phase 1a/1b trial conducted by Eli Lilly and Company and will last up to about four years. The study consists of two parts: phase 1a, which involves dose escalation and optimization of LY4170156 alone or in combination with other drugs such as bevacizumab, carboplatin, itraconazole, and pembrolizumab, all given intravenously or orally as appropriate; and phase 1b, which is a dose-expansion phase to further assess the drug's effects. Participants may receive LY4170156 alone or with these additional treatments in various dosing schedules. During the trial, participants will undergo assessments to determine the recommended phase 2 dose, monitor antitumor activity, and track serious adverse events related to the drug over up to four years. Researchers will measure outcomes such as overall response rate, duration of response, time to response, progression-free survival, and disease control rate. Blood samples and pharmacokinetic studies will be conducted during the first 84 days to understand how the drug behaves in the body. Safety and tolerability will be closely monitored throughout the study.

A Study of LY4170156 in Participants With Selected Advanced Solid Tumors