Initiation of Phase 1/2 clinical trial of MT-4561 for Advanced Solid Tumors

June 13, 2025 Initiation of Phase 1/2 clinical trial of MT-4561 for Advanced Solid Tumors Mitsubishi Tanabe Pharma Corporation (Head Office: Chuo- ku, Osaka; President, Representative Director: Akihiro Tsujimura, “MTPC”) announced today that the first patient has dosed in its Phase I/II study of MT-4561 in patients with advanced solid tumors in May in the U.S. MT-4561 is a novel BRD4 degrader that exerts continuous anti-tumor effects in various cancer xenograft models and patient derived cells. BRD4 is responsible for promoting transcription of cancer related genes and degradation of BRD4 can result in rapid induction of apoptosis and death of transcriptionally addicted cancers. Mitsubishi Tanabe Pharma America is developing MT-4561 as a potential treatment option for advanced solid tumors. The Phase I/II study ( NCT06943521), is a human, multicenter, open-label study, that evaluates safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of MT- 4561 in patients with advanced solid tumors. The clinical trial for MT-4561 will be conducted in 3 parts, across several sites, with the first part consisting of an intravenous infusion of MT-4561 once every week in 28-day cycle that evaluates the number of patients with adverse events and the incidence of dose limiting toxicities (DLT). The study details and doses of Part 2 (dose-optimization) and Part 3 (Drug- Drug Interaction) will be available after review of applicable Part 1 results. Leveraging its strengths in drug discovery, MTPC Group will take on the new challenge of oncology and strive to bring new treatments options to patients suffering from cancer. Contact: Mitsubishi Tanabe Pharma Corporation CEO Office PR Group +81-6-6205-5119

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