Phase II Study Evaluating SKB571 Infusion Safety and Effectiveness in Adults With Gastrointestinal Tumors

What this Trial Is About

Researchers are conducting an open-label, multicenter Phase II study to assess the safety, tolerability, and preliminary anti-tumor effects of SKB571 in adults with gastrointestinal tumors. This study aims to evaluate how well SKB571 works and its pharmacokinetic and immunogenic properties in about 120 participants divided into four cohorts based on tumor type. Participants will receive SKB571 by intravenous infusion every three weeks. The study includes four groups focusing on different gastrointestinal tumor types, including gastric, esophageal, colorectal, and liver or bile duct cancers. This treatment phase will be followed for up to approximately 24 months to monitor outcomes. During the study, participants will undergo assessments for tumor response, survival, and disease control, along with safety checks. Blood samples will be taken to analyze drug concentrations and immune response. Researchers will closely monitor participants health and document any side effects or adverse events. The total study duration extends through mid-2028.

A Study of SKB571 in Participants With Gastrointestinal Tumors