Lexington

Researchers are evaluating TORL-4-500, an antibody drug conjugate, in adults with advanced or metastatic solid tumors, including hepatocellular carcinoma and adrenocortical carcinoma, in this first-in-human Phase 1 study. The trial aims to assess the safety, tolerability, how the drug moves through the body, and its antitumor effects in patients with advanced cancer. Participants receive TORL-4-500 intravenously once every three weeks. The study includes two parts: Part 1 focuses on dose finding to determine the maximum tolerated dose and recommended dose for future studies. Part 2 expands on this by further assessing the drug as a monotherapy at the selected dose. During the study, participants will have regular evaluations for side effects and serious adverse events up to two years. Researchers will monitor tumor response, duration of response, progression-free survival, and overall survival. Blood samples will be taken to measure drug levels and immune response. The total study duration varies, with some assessments occurring up to two years after treatment begins to ensure thorough safety and effectiveness monitoring.