Phase 1 Study of Oral DEG6498 for Safety and Dosing in Adults With Advanced Solid Tumors Including BRAF Mutant Tumors and Hepatocellular Carcinoma

What this Trial Is About

Researchers are evaluating DEG6498, an oral molecular glue drug, in participants with advanced solid tumors to understand its safety, tolerability, and how the body processes it. This first-in-human Phase 1 study will also explore the appropriate dosing and potential anti-tumor effects of DEG6498. The study is open-label and conducted at multiple centers, focusing on participants who have no alternative treatment options. The study has two parts Part 1 involves dose escalation where different doses of DEG6498 are tested once daily in 28-day treatment cycles to find the maximum tolerated dose and recommended dose for further research. Part 2 is a dose expansion phase that will assess safety and clinical activity of DEG6498 at the selected dose in patients with BRAF mutant tumors and hepatocellular carcinoma HCC. Participants will take DEG6498 capsules daily and be closely monitored through screening, treatment cycles, and follow-up visits. Researchers will evaluate side effects, drug levels in the body, tumor responses, and overall safety over treatment periods averaging six months and up to 30 months for response duration. Safety monitoring continues for 30 days after the last dose to ensure participant well-being throughout the study.

A Study of DEG6498 in Participants With Solid Tumors