Phase 1 Study to Evaluate Safety and Pharmacokinetics of Oral ABSK061 in Adults with Advanced Solid Tumors

What this Trial Is About

This research aims to study the safety and tolerability of an oral drug called ABSK061 in patients with advanced solid tumors. The trial is an open-label phase 1 study that starts with dose escalation to find the maximum tolerated dose or maximum administered dose. The study includes patients with solid tumors who have progressed on or cannot tolerate standard treatments. The expansion phase focuses on specific tumor types with certain genetic changes and further evaluates safety and antitumor activity. During the dose escalation phase, patients receive a single dose of ABSK061 on the first day of cycle 1, followed by twice-daily dosing for the rest of the 28-day cycle and subsequent cycles. The dose is adjusted based on safety data using a Bayesian optimal interval design. In the expansion phase, patients receive the drug at the recommended dose for repeated 28-day cycles. Some regions may enroll a small number of local patients first to confirm safety before full expansion. Participants will undergo regular assessments including monitoring for dose-limiting toxicities and adverse events over about six months. Researchers will also measure drug levels and antitumor responses such as objective response rate, duration of response, disease control rate, and progression-free survival. Eligibility involves performance status, life expectancy, organ function, and specific tumor genetic tests. Safety monitoring continues throughout the study, which lasts several months per participant.

A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK061 in Patients With Advanced Solid Tumors