Phase 1 Study of Oral HQP1351 for Safety and Initial Effectiveness in Patients with Gastrointestinal Stromal Tumor or Other Solid Tumors

What this Trial Is About

Researchers are evaluating HQP1351, an oral drug, in patients aged 12 years and older with gastrointestinal stromal tumors GIST or other solid tumors that are advanced or metastatic. This phase 1, multi-center, open-label study aims to find the recommended dose for phase 2 and assess how the drug behaves in the body, its safety, and its preliminary effects on tumors. The trial is sponsored by Ascentage Pharma Group Inc. and uses a randomized design without masking. Participants receive HQP1351 orally once every other day for consecutive 4-week cycles. The study includes several dose groups 20 mg, 30 mg, 40 mg, and 50 mg every other day, with minor subjects enrolled based on weight. The treatment period continues with dose adjustments to find the optimal dose. The study focuses on safety, tolerability, pharmacokinetics, and pharmacodynamics of HQP1351. During the study, participants are monitored for safety and treatment tolerance up to 30 days after the last dose. Researchers measure the drugs concentration in plasma on specific days of the first cycle and observe anti-tumor activity over months. Participants undergo evaluations of blood counts, organ function, heart function, pregnancy testing for women, and follow study procedures including consent and follow-up visits. The trial is expected to continue until December 2028.

A Study of HQP1351 in Patients With GIST or Other Solid Tumors