An Open-Label, Multicenter, Phase IB/II Clinical Study of HRS-7172 in Combination With Antitumor Therapy in Participants With Solid Tumors

Summary

This is a Phase IB/II clinical trial designed to evaluate HRS-7172 in combination with antitumor drugs in participants with advanced pancreatic cancer harboring RAS mutations or amplifications. The study process includes a screening period (from signed informed consent to first dose), a treatment period (from first dose to last dose), and a follow-up period (safety and survival follow-up after last dose). A Safety Monitoring Committee (SMC), composed of the principal investigator and sponsor representatives, will be established during the study to review the safety and efficacy data generated. The SMC will make decisions on study-related matters, including but not limited to combination regimen dose exploration, combination regimen selection, efficacy expansion cohort selection, expansion initiation timing, and recommended dose for expansion (RDE). This study aims to evaluate the safety, tolerability, and efficacy of HRS-7172 in combination with other antitumor therapies in participants with advanced or metastatic pancreatic cancer harboring RAS mutations or amplifications.

Timeline

Start

2026-09

Primary completion

2028-12-31

Completion

2029-12-31

Drugs

Indications