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Phase 1
Age: 18Years +
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ID03917043

Safety and Effects Study of Oral APG-2449 in Adults with Advanced Solid Tumors Including Lung, Esophageal, Ovarian Cancer, and Mesothelioma

Led by Ascentage Pharma Group Inc. · Updated on 2026-07-23

165

Participants Needed

9

Research Sites

4 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are studying APG-2449, a new oral drug that targets multiple tyrosine kinases including FAK, ALK, and ROS1. This study focuses on adults with advanced solid tumors such as non-small cell lung cancer, esophageal cancer, ovarian cancer, and malignant pleural mesothelioma. The goal is to find the safest dose and understand the drugs effects in patients who have advanced cancers, including those resistant to other therapies. Participants will receive APG-2449 capsules daily in 28-day cycles. The study starts with a dose escalation phase using a standard 33 design to identify the maximum tolerated dose and recommended dose for future studies. About 30 to 40 patients will be treated at the determined safe dose level to further evaluate safety and preliminary effectiveness. During the trial, participants will undergo regular assessments including measuring drug levels in the blood, tumor response evaluations every 4 weeks, and monitoring of side effects. Researchers will also collect tumor tissue samples before treatment and monitor performance status and organ functions. The study may last until December 2027 with ongoing safety and efficacy evaluations throughout the treatment cycles.

CONDITIONS

Brief Title

APG-2449 in Patients With Advanced Solid Tumors

Research Team

Y

Yifan Zhai, M.D., Ph.D.

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