Phase III Study to Assess Safety, Dosage, and Effectiveness of MT-4561 in Adults With Various Advanced Solid Tumors

What this Trial Is About

Researchers are evaluating MT-4561, an investigational drug, in adults with various advanced solid tumors including head and neck, lung, esophageal, gastric, biliary tract, pancreatic, breast, ovarian, cervical, endometrial, prostate, urothelial, neuroendocrine tumors, soft tissue sarcoma, and NUT carcinoma. This Phase III study aims to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and effectiveness of MT-4561 in patients who have exhausted other treatment options or cannot tolerate standard therapies. The study is sponsored by Tanabe Pharma America, Inc. The study is conducted in three parts. Part 1 focuses on finding the maximum tolerated dose using a dose-escalation design with weekly intravenous infusions of MT-4561 in 28-day cycles until disease progression or stopping criteria are met. Parts 2 and 3 will explore dose optimization and drug interactions after reviewing Part 1 results. Participants receive the study drug via intravenous infusion once a week during each 28-day cycle. Participants will be regularly monitored for side effects, dose-limiting toxicities, and drug levels in blood. Researchers will assess tumor response and disease control over approximately three years. Evaluations include physical exams, lab tests, and imaging to measure tumor changes, survival, and duration of disease stability. The study includes screening, treatment cycles, and follow-up visits to track safety and outcomes throughout the trial period.

A Study of MT-4561 in Patients With Various Advanced Solid Tumors