A Study of MT-4561 in Patients With Various Advanced Solid Tumors
Recruiting now · Phase 1/Phase 2
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
In brief
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.
Key facts
- Study ID
- NCT06943521
- Run by
- Tanabe Pharma America, Inc.
- People needed
- 27
- Starts
- 2025-04-18
- Expected to finish
- 2028-08-01
- Last updated by the study team
- 2025-12-11
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- University of Southern California — Los Angeles, California, United States (enrolling)
- START Midwest — Grand Rapids, Michigan, United States (enrolling)
- The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer Center — Columbus, Ohio, United States (enrolling)
- The University of Texas MD Anderson Cancer Center — Houston, Texas, United States (enrolling)
- National Cancer Center Hospital — Chuo-Ku, Tokyo, Japan (enrolling)
- National Cancer Center Hospital East — City, Japan (enrolling)
Full record on ClinicalTrials.gov
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