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Study identifier: NCT06943521 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

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

Condition: Head and Neck Squamous Cell Carcinoma (HNSCC) · Non-small Cell Lung Cancer (NSCLC) · Esophageal Cancer  ·  Sponsor: Tanabe Pharma America, Inc.

PhasePhase 1/Phase 2
Planned participants27
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Clinical Trials Information Desk, to prevent miscommunication,  ·  Please E-mail  ·  information.US@mb.tanabe-pharma.com

Always discuss trial participation with your own doctor first.

Locations (6)

University of Southern CaliforniaLos Angeles, California, United StatesRecruiting
START MidwestGrand Rapids, Michigan, United StatesRecruiting
The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer CenterColumbus, Ohio, United StatesRecruiting
The University of Texas MD Anderson Cancer CenterHouston, Texas, United StatesRecruiting
National Cancer Center HospitalChuo-Ku, Tokyo, JapanRecruiting
National Cancer Center Hospital EastCity, JapanRecruiting

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Source record: clinicaltrials.gov/study/NCT06943521