Phase 1 Study of HS-20124 Drug for Safety and Effectiveness in Adults with Advanced Solid Tumors

What this Trial Is About

Researchers are studying HS-20124, a new antibody-drug conjugate targeting CDH6, in patients with advanced solid tumors. This Phase 1a1b open-label, multicenter trial aims to find the highest tolerated dose and assess safety, how the drug moves through the body, and early signs of anti-tumor activity. The trial includes patients with tumors that do not respond to standard treatments or for whom such treatments are not suitable. Participants receive HS-20124 through intravenous infusion in 21-day cycles. The study has two parts dose escalation using a rolling-6 design to find the maximum tolerated dose, followed by dose expansion where selected doses are tested further for preliminary effectiveness in specific tumor types. Treatment continues until unacceptable side effects or clear disease progression occur. During the study, participants undergo imaging to measure tumor response compared to their baseline tumor size. Researchers monitor treatment-emergent side effects, drug levels in blood, immune response, and tumor response using established criteria. Safety is followed through 30 days after treatment ends. Participants are assessed regularly until disease progression or withdrawal. The study will continue until late 2027.

A Study of HS-20124 in Patients with Advanced Solid Tumors