Phase II Study of HRS-7058 with Anti-tumor Drugs for Adults with Solid Tumors Assessing Safety, Tolerability, and Treatment Response

What this Trial Is About

Researchers are studying the safety, tolerability, and recommended dose of HRS-7058 combined with antitumor drugs in people with solid tumors. The study also aims to evaluate how well this combination works by measuring the objective response rate in these patients. This is a Phase II clinical trial sponsored by Shandong Suncadia Medicine Co., Ltd., focusing on adults aged 18 to 75 with measurable solid tumors. Participants will receive HRS-7058 together with antitumor drugs. The study includes monitoring for dose-limiting toxicities and adverse events during about 28 days after treatment starts. The recommended Phase II dose will be determined over approximately 12 months, with ongoing evaluation of treatment effects including response duration, disease control, progression-free survival, overall survival, drug blood levels, and antibody responses. During the study, participants will undergo various examinations, tumor tissue sampling, and regular assessments of treatment effects and side effects. Tests will include tumor measurements based on RECIST standards, blood tests for drug concentration and immune response, and monitoring for adverse events. The total participation lasts about 12 months from the first dose to the last visit, ensuring close observation of both safety and treatment outcomes.

A Clinical Trial of HRS-7058 Combined Anti-tumor Drugs in Subjects With Solid Tumors