Phase 12 Study of APL-5125 Oral Capsules to Treat Adults with Advanced Solid Tumors, Focused on Colorectal Cancer

What this Trial Is About

Researchers are evaluating APL-5125, an investigational oral drug, for its safety, tolerability, and anti-tumor activity in adults with selected advanced solid tumors, focusing especially on colorectal cancer. This open-label study includes both Phase 1 and Phase 2 stages to explore APL-5125s effects in patients with various cancers that have advanced locally or spread to other parts of the body. The study involves a Phase 1 dose escalation to find the recommended dose for Phase 2 by administering increasing oral doses of APL-5125 daily in 28-day cycles. Following dose identification, Phase 2 expands to assess the drugs activity in colorectal cancer patients. Participants receive at least two dose levels, with tumor response assessments every 8 weeks initially and every 12 weeks after one year, continuing for up to two years. Participants will be monitored for treatment-emergent side effects, dose-limiting toxicities, and drug pharmacokinetics through scheduled visits and laboratory tests across the study. Safety and tumor biomarkers will be evaluated throughout approximately one to two years. The study requires regular assessments including tumor response scans and blood tests to ensure participant safety and to measure the drugs effects over time.

A Study to Investigate APL-5125 in Adults With Advanced Solid Tumors