Phase I Study of BGC515 Capsules to Evaluate Safety and Early Effectiveness in Adults With Advanced Solid Tumors

What this Trial Is About

Researchers are conducting a Phase I open-label clinical trial to study BGC515 capsules in patients with advanced solid tumors, including mesothelioma and epithelioid hemangioendothelioma. The trial aims to evaluate the safety, tolerability, how the drug is processed in the body, and preliminary effectiveness of BGC515 when given once daily in 3-week cycles. This early-phase study will help determine the best dose for future treatment evaluations. Participants will take BGC515 capsules orally once a day in 21-day cycles. The study has two main parts a dose escalation phase where increasing doses are tested to find the highest tolerable dose and recommended dose for further study, followed by a dose expansion phase where the drug is given at that determined dose to patients with specific tumor types or tumors with certain molecular features. Treatment continues in cycles as long as it is safe and effective. During the study, participants will be closely monitored for side effects and drug levels in the blood at various time points up to about one year. Researchers will measure adverse events, dose-limiting toxicities, response rates, and progression-free survival over approximately three years. The study also tracks how the drug is absorbed and cleared from the body. Participants will undergo regular assessments and safety checks throughout their involvement, which may last several years.

A Study of BGC515 Capsules in Subjects With Advanced Solid Tumors