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

Summary

This is a First In Human (FIH), multicenter, open-label, Phase I/II study to evaluate safety, tolerability, Pharmacokinetics (PK), pharmacodynamics, and efficacy of MT-4561 in patients with advanced solid tumors. This study will be conducted in 3 parts. Part 1 is aimed at evaluating safety, tolerability, PK and pharmacodynamics of MT-4561 and determining the Maximum Tolerated Dose (MTD) using the Bayesian Optimal Interval (BOIN) design. 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.

Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov

Conditions studied

• Head and Neck Squamous Cell Carcinoma (HNSCC)
• Non-small Cell Lung Cancer (NSCLC)
• Esophageal Cancer
• Gastric Cancer
• Biliary Tract Cancer
• Pancreatic Ductal Adenocarcinoma (PDAC)
• Breast Cancer
• Ovarian Cancer
• Cervical Cancer
• Endometrial Cancer
• Prostate Cancer
• Urothelial Carcinoma
• Neuroendocrine Tumor (NET)
• Neuroendocrine Carcinoma (NEC)
• Soft Tissue Sarcoma
• Nuclear Protein in Testis (NUT) Carcinoma

Eligibility basics and study details

Study type

Interventional

Phase

Phase 1/2

Ages

18 years and older

Sex

All

Healthy volunteers

Not accepted

Sponsor

Tanabe Pharma America, Inc.

Last updated on ClinicalTrials.gov

December 11, 2025

These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.

US recruiting sites