Phase 12 Study of Emiltatug Ledadotin Emi-Le Given Intravenously to Treat Advanced or Recurrent Solid Tumors Including Adenoid Cystic Carcinoma

What this Trial Is About

Researchers are evaluating a drug called Emi-Le Emiltatug Ledadotin in participants with various solid tumors, including recurrent, advanced, or metastatic cancers such as breast, endometrial, ovarian, fallopian tube, primary peritoneal cavity cancers, and adenoid cystic carcinoma. This first-in-human study aims to test the safety, side effects, and anti-tumor activity of Emi-Le. The trial includes dose-finding, safety, and effectiveness phases to better understand Emi-Les role in treating these cancers. The study has three parts Dose Escalation, Dose Expansion, and a Phase 2 part called EMBLEM-1. In Dose Escalation, researchers determine the appropriate dose of Emi-Le. Then, Dose Expansion uses that dose to further assess safety and response in solid tumors. In EMBLEM-1, the focus is on evaluating Emi-Les effect on aggressive Adenoid Cystic Carcinoma and continuing safety monitoring. Emi-Le is given intravenously through a vein or port catheter. Participants will undergo screenings including tumor tissue collection for testing and brain MRI if indicated. During treatment, researchers will monitor adverse events, tumor response, survival, and other health measures over up to approximately three years. The main outcomes include frequency of dose-limiting toxicities, overall response rate, and safety. The study involves regular assessments to track Emi-Les impact and participants well-being throughout the trial.

A Study of Emiltatug Ledadotin (Emi-Le) in Participants With Solid Tumors