Phase III Study of HRS-6719 in Adults With MTAP-Deficient Advanced or Metastatic Solid Tumors Evaluating Safety, Drug Effects, and Early Efficacy

What this Trial Is About

Researchers are studying the safety, tolerability, pharmacokinetics, pharmacodynamics, and antitumor effects of the drug HRS-6719 in patients with advanced or metastatic solid tumors that lack the MTAP gene. This Phase III, open-label, multicenter trial includes dose escalation, dose expansion, and efficacy expansion phases to better understand how the drug behaves and its potential benefits for this patient group. Participants receive HRS-6719 as the experimental treatment. The study is organized into phases that assess dose limits and tolerability during the first 21-day cycle, followed by evaluations of efficacy and recommended dosing. The trial does not include placebo controls and is open-label, meaning patients and researchers know the treatment being given. During the study, participants will be closely monitored for dose-limiting toxicities, adverse events, and other safety measures. Researchers will collect data on tumor response rates, duration of response, disease control, time to response, progression-free survival, and overall survival up to one year after treatment. The trial includes assessments of organ function, tumor tissue analysis, and other health evaluations to track the drugs effects and participant well-being throughout the study period, which may last up to several years.

A Phase I/II of HRS-6719 in Patients With Advanced/Metastatic Solid Tumors