A Dose Escalation and Dose Optimization Phase 1a/1b Study to Evaluate Safety, Tolerability and Dosimetry of Radioligand Therapy With LY4337713 in Adults With FAP-Positive Solid Tumors (FiREBOLT)

What this Trial Is About

Researchers are evaluating LY4337713, a drug given intravenously, in adults with advanced or spreading solid tumors that show high levels of a protein called fibroblast activation protein (FAP). This phase 1a/1b study aims to assess the safety, side effects, and how well LY4337713 works. It also studies how the drug is absorbed, processed, and eliminated by the body over about five years for each participant. Participants will receive escalating doses of LY4337713 through IV infusion. Several dose regimens are tested during dose escalation, and specific tumor cohorts receive LY4337713 intravenously. The study includes multiple groups receiving the experimental drug under different dosing schedules. The treatment period is followed by long-term follow-up to monitor effects and responses. During the study, participants will undergo regular assessments including imaging to evaluate tumor response, laboratory tests to monitor drug levels and organ function, and safety checks for side effects. Researchers will measure dose-limiting toxicities within the first 28 days and track tumor responses up to five years. Participants will be closely monitored for tolerability and disease control throughout the study period.

A Study of LY4337713 in Participants With FAP-Positive Solid Tumors