Actively Recruiting
Phase 1 Study of PEP08 for Safety and Early Effectiveness in Adults with Advanced or Metastatic MTAP-Deleted Solid Tumors
Led by PharmaEngine · Updated on 2026-02-13
40
Participants Needed
4
Research Sites
13 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating PEP08, a new oral cancer therapy, in patients with advanced or metastatic solid tumors that have a specific genetic change called MTAP deletion. This early-phase study focuses on understanding the safety, tolerability, and initial anti-tumor effects of PEP08 when given alone or combined with other treatments. The study aims to find the best dose for future research and assess how the drug behaves in the body. Participants will receive PEP08 daily in a dose-escalation phase to test safety and response. The study is divided into three parts Part 1 focuses on increasing doses of PEP08 alone, with Parts 2 and 3 planned for future phases involving extended monotherapy and combination treatments. Treatment continues until disease progression, unacceptable side effects, withdrawal, or study end. Throughout the study, participants will attend regular clinic visits for treatment, lab tests, and tumor scans to monitor effects and safety. Researchers will track adverse events, drug levels in the blood, and tumor responses over time, with safety assessments lasting up to two years. The study started in August 2025 and continues through March 2028.
CONDITIONS
Brief Title
A Study of PEP08 in Patients With MTAP-Del Advanced or Metastatic Solid Tumors
Research Team
P
Project Manager
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