Phase 2 Study of HS-20093 Antibody-Drug Therapy for Head and Neck Squamous Cell Carcinoma and Other Advanced Solid Tumors

What this Trial Is About

Researchers are evaluating HS-20093, a fully humanized IgG1 antibody-drug conjugate that specifically targets B7-H3, a protein commonly found on solid tumor cells. This phase 2, open-label, multi-center study aims to assess the effectiveness, safety, how the body processes the drug, and immune response in patients with head and neck squamous cell carcinoma HNSCC and other solid tumors who have progressed on or cannot tolerate standard treatments. The study includes two parts Phase 2a with patients having recurrent or metastatic HNSCC or other advanced solid tumors, and Phase 2b with patients having recurrent or metastatic HNSCC. All participants will receive HS-20093 at a dose of 10 mgkg. Patients may continue receiving the treatment if it is well tolerated and provides ongoing clinical benefit. Safety will be monitored during treatment and for 90 days after the last dose. Participants will undergo regular assessments including tumor measurements based on RECIST 1.1 criteria, blood tests to study drug levels and immune response, and monitoring for side effects. The main outcome is the objective response rate up to 24 months. Secondary outcomes include safety evaluations, drug concentration levels, duration of response, disease control, progression-free survival, and overall survival. The study follow-up lasts up to two years to fully capture treatment effects and safety.

ARTEMIS-006: HS-20093 in Patients With Head and Neck Squamous Cell Carcinoma and Other Solid Tumors