Open Label Phase 12 Study of HRS-8364 Tablets for Treating Advanced Solid Tumors

What this Trial Is About

Researchers are conducting an open, multicenter Phase III clinical trial to study HRS-8364 in adults with advanced solid tumors. The study aims to evaluate the safety, tolerability, pharmacokinetics, and effectiveness of HRS-8364 in patients whose cancer has progressed despite standard treatments or who have no standard treatment options. This trial is sponsored by Jiangsu HengRui Medicine Co., Ltd. Participants will receive HRS-8364 tablets at various doses through different stages of the study dose escalation, dose expansion, and efficacy expansion. The trial will assess the best dose for further study, monitor side effects, and evaluate the drugs impact on tumor response. Treatment and follow-up will last about one year, with close monitoring of drug levels and patient health. During the trial, participants will undergo regular assessments including evaluations of tumor size based on RECIST criteria, safety checks, and blood tests to monitor drug concentration and effects. Researchers will track outcomes like dose-limiting toxicity, response rates, disease control, and progression-free survival. The study includes safety follow-up and requires participants to comply with contraception guidelines if applicable, lasting from enrollment through about one year of treatment and follow-up.

A Clinical Study of HRS-8364 in the Treatment of Advanced Solid Tumor Subjects