Phase 2 Study of HS-20093 Treatment for Advanced Esophageal Carcinoma and Other Solid Tumors in Adults

What this Trial Is About

Researchers are evaluating HS-20093, a humanized IgG1 antibody-drug conjugate that targets B7-H3, which is commonly found on solid tumor cells. This open-label, multi-center phase 2 study focuses on Chinese adults with recurrent, locally advanced, or metastatic esophageal carcinoma and other advanced solid tumors. The study aims to assess the anti-tumor activity, safety, pharmacokinetics, and immune response of HS-20093. The study is divided into two parts phase IIa and phase IIb. In phase IIa, participants with relapsed, locally advanced, or metastatic esophageal carcinoma and other solid tumors will receive intravenous doses of HS-20093 every three weeks. Phase IIb will enroll participants specifically with relapsed, locally advanced, or metastatic esophageal squamous cell carcinoma, also receiving HS-20093 by intravenous infusion every three weeks. Treatment continues until unacceptable side effects occur or the disease progresses. Participants will undergo regular evaluations including tumor assessments according to RECIST 1.1 criteria to measure response rate, duration of response, disease control, progression-free survival, and overall survival up to 24 months. Safety is monitored through adverse event tracking up to 90 days after the last dose. Blood samples will be collected to analyze drug levels and immune reactions. The study duration includes treatment and follow-up to monitor these outcomes and overall participant health.

HS-20093 in Patients with Advanced Esophageal Carcinoma and Other Advanced Solid Tumors