Anderson

Researchers are evaluating the safety and early effectiveness of DB-1311 combined with either BNT327 or DB-1305 in adults with advanced or metastatic solid tumors. This phase II, multicenter, open-label trial includes participants with several types of cancer, including hepatocellular carcinoma, cervical cancer, melanoma, head and neck squamous cell carcinoma, platinum-resistant ovarian cancer, and non-small cell lung cancer. The study focuses on targeted patients whose cancers have recurred, progressed, or are difficult to treat. The trial involves two treatment combinations delivered intravenously: DB-1311 with BNT327, and DB-1311 with DB-1305. Participants receive these investigational drug combinations under close observation. The study is divided into two parts: the first part evaluates dose-limiting toxicities within 21 days after the first dose, while the second part assesses treatment safety and response rates up to 72 months. This design allows researchers to monitor both short-term safety and long-term treatment effects. During the study, participants undergo regular assessments including monitoring for adverse events, tumor response evaluations using RECIST criteria, and organ function tests. The primary outcomes include the number of participants experiencing dose-limiting toxicities early in treatment and the objective response rate, which measures the proportion of participants showing significant tumor shrinkage. Safety monitoring continues throughout the study duration, with follow-up visits extending up to six years to observe long-term effects and participant health.