Phase 1 Study of Oral ABSK131 for Safety and Early Effectiveness in Adults With MTAP-Deficient Advanced or Metastatic Solid Tumors

What this Trial Is About

Researchers are evaluating ABSK131 in patients with MTAP-Deficient advanced or metastatic solid tumors in a first-in-human, multicenter, open-label phase 1 study. The study aims to assess the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of ABSK131 in this patient population. This research includes patients who have progressed on or are intolerant to standard therapies or have no standard treatment options available. The study begins with a dose escalation phase where patients receive ABSK131 in repeated 21-day cycles. Initially, a single oral dose is given, followed by a two-day run-in period to assess drug pharmacokinetics. Patients then take daily oral doses continuously. Following dose escalation, an expansion phase will administer ABSK131 at the recommended dose to further evaluate safety, tolerability, and preliminary efficacy. Up to 86 patients may enroll in dose escalation, and up to 180 patients in the expansion phase. Participants will be monitored from the time of informed consent through up to 30 months after the last dose to assess adverse events, serious events, and immune-related effects. Pharmacokinetic measures such as drug concentration and half-life will be tracked, along with tumor response and progression. Life expectancy, organ function, performance status, and blood pressure will be evaluated before treatment. Follow-up for survival may extend up to 60 months, supporting comprehensive safety and efficacy assessment over time.

A Early Study of ABSK131 in Patients With Advanced/Metastatic Solid Tumors