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

Study 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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedMT-4561

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC)

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Dec 11, 2025 · Source: ClinicalTrials.gov

Is enrollment open?Recruiting

The study is currently accepting participants.

What kind of study?Phase 1 / Phase 2

Interventional

Where is it offered?6 U.S. locations

Locations may change over time.

Who runs it?Tanabe Pharma America, Inc.

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Phase 1 / Phase 2
Sponsor: Tanabe Pharma America, Inc.
Interventions being studied: Drug: MT-4561

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type

Non-small cell lung cancer (NSCLC)→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

Main Patients who have failed at least 1 prior therapy and, who have no standard treatment options demonstrated to provide clinical benefit or who are intolerable to or refuse further standard therapies will be enrolled.
Male or female patient aged 18 years or older at the time of signing the informed consent form
≥ 1 measurable lesion by the RECIST v1.1
Eastern Cooperative Oncology Group (ECOG) performance status: 0 to 1
Life expectancy of at least 3 months
Adequate bone marrow function
Adequate hepatic function
Adequate renal function estimated creatinine clearance ≥ 60 mL/min calculated using the Cockcroft and Gault equation or by institutional method
Part 1: Patients must have a confirmed histologic or cytologic diagnosis of one of the following solid tumors for participation in the study: 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) or neuroendocrine carcinoma (NEC), soft tissue sarcoma, and NUT carcinoma. Main

Reasons someone may not be able to joinExclusion criteria

Patients with active brain or leptomeningeal metastases
Any unresolved toxicity ≥ Grade 2 from previous anticancer therapy except for alopecia
Prior systemic anticancer therapy within 4 weeks before first dose of investigational medicinal product (IMP) or 5 half-lives, whichever is shorter, and prior radiotherapy within 2 weeks before first dose of IMP
History of congenital long QT syndrome or clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation or Torsades de pointes)
Patients who received drugs with a known risk of QT interval prolongation or Torsades de pointes within 14 days or 5 half-lives, whichever is shorter, before the start of IMP administration
QT interval corrected for heart rate using Fridericia's correction (QTcF) \> 470 msec at screening

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

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

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Dec 11, 2025. Always confirm current availability with the study team.

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