Phase 1 Study of SHR-A1811 Subcutaneous Injection to Assess Safety, Pharmacokinetics, and Effectiveness in Adults with Solid Tumors

What this Trial Is About

Researchers are evaluating the pharmacokinetics, safety, tolerability, and effectiveness of SHR-A1811 subcutaneous injection in patients with solid tumors. This phase 1, open-label study aims to understand how the drug behaves in the body and its impact on tumor response. The study is sponsored by Suzhou Suncadia Biopharmaceuticals Co., Ltd., and involves adult patients with confirmed solid tumors. Participants will receive SHR-A1811 through subcutaneous injection in one of three dose groups low, medium, or high dose. This non-randomized study observes patients over approximately 72 weeks, focusing on drug levels in the blood and adverse effects. The study does not use placebo or blinding methods. Throughout the study, patients will undergo assessments including blood tests to measure drug concentration and immune response, evaluation of tumor size using RECIST criteria, and monitoring for side effects and dose-limiting toxicities. Researchers will track survival outcomes and disease control rates. Participants will be followed closely for safety and treatment response during the entire study period.

A Clinical Study of SHR-A1811(sc) Subcutaneous Injection in Patients With Solid Tumor