Anderson

Researchers are evaluating the safety and preliminary effectiveness of DB-1311 combined with BNT327 or DB-1305 in adults with advanced or metastatic solid tumors. This phase II, open-label, multicenter trial includes participants with various cancers such as hepatocellular carcinoma, cervical cancer, melanoma, head and neck squamous cell carcinoma, ovarian cancer, non-small cell lung cancer, pancreatic ductal carcinoma, breast cancer, colorectal cancer, and metastatic castration-resistant prostate cancer. The trial involves escalating doses of the drug combinations DB-1311BNT324 with either BNT327 or DB-1305BNT325. These treatments are given intravenously to define recommended phase 2 doses in different patient groups. Participants are assigned to one of several study arms based on their cancer type and dose level, with treatment continuing as per protocol. The study aims to establish safe dosing and observe treatment responses over time. Participants will undergo regular assessments including monitoring for dose-limiting toxicities and adverse events up to 72 months. The study will measure tumor response using RECIST 1.1 criteria and evaluate overall survival, progression-free survival, and other outcomes. Blood samples will be collected to study drug concentrations and immune responses. The trial includes follow-up visits to monitor safety and effectiveness throughout the study duration.