Phase 1 Open-Label Study of Oral ABSK-011 for Safety and Pharmacokinetics in Adults with Advanced Solid Tumors Including Liver Cancer

What this Trial Is About

Researchers are conducting an open-label phase 1 trial to evaluate the safety, tolerability, and pharmacokinetics of the oral drug ABSK-011 in patients with advanced solid tumors. The study includes an escalation part to determine the recommended dose for expansion and an expansion part focusing on patients with advanced liver cancer HCC who have FGF19 overexpression. The trial also explores preliminary antitumor activity of ABSK-011 in this group. During the escalation phase, participants receive a single dose of ABSK-011 followed by a 1-day break to assess pharmacokinetics before continuing daily or twice-daily dosing in 28-day cycles. Dose increases follow a 33 design except for an accelerated titration cohort. In the expansion phase, patients are treated at the recommended dose determined from escalation. A food effect cohort may also be studied. Participants undergo regular monitoring including physical exams, ECOG performance status, ECGs, echocardiograms, and vital signs throughout the study, lasting about six months on average. The team tracks dose-limiting toxicities, adverse events, and treatment adjustments. Pharmacokinetic measures are collected during the first treatment cycle. Tumor response and disease control are also assessed over the study period. Follow-up includes safety and tolerability evaluations after treatment completion.

A Study to Assess the Safety, Tolerability, and Pharmacokinetics of ABSK-011 in Patients With Advanced Solid Tumor