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

December 4, 2025 updated by: Tanabe Pharma America, Inc.

A Phase I/II, Dose-escalation and Dose-optimization Study to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of MT-4561 in Patients With Various Advanced Solid Tumors and to Evaluate Effect of MT-4561 on Pharmacokinetics of Oral Midazolam

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

27

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Japan
      • City, Japan
        • Recruiting
        • National Cancer Center Hospital East
    • Tokyo
      • Chuo-Ku, Tokyo, Japan, 104-0045
        • Recruiting
        • National Cancer Center Hospital
  • United States
    • California
      • Los Angeles, California, United States, 90033
        • Recruiting
        • University of Southern California
    • Michigan
      • Grand Rapids, Michigan, United States, 49546
        • Recruiting
        • Start Midwest
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer Center
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • The University of Texas MD Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Main Inclusion Criteria:

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 Exclusion 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Part 1 (Dose-escalation)
Intravenous (IV) infusion of MT-4561 once every week in 28-day cycle, until disease progression or discontinuation criteria are met.
Drug: MT-4561
i.v.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Adverse Event, Dose limiting toxicities (DLTs)
Time Frame: a 28-day cycle

Part 1 Frequency, duration, and severity (Common Terminology Criteria for Adverse Events [CTCAE] v5.0) of adverse events, dose limiting toxicity (DLT), physical examinations, changes in clinical laboratory values (e.g., hematology, chemistry, and urinalysis), vital signs (e.g., heart rate, blood pressure, respiratory rate), electrocardiogram

DLTs are defined as any event meeting the DLT criteria at least possibly related to MT-4561 for Cycle 1 (i.e., DLT monitoring window is approximately 28 days). Events with a clear alternative explanation will not be considered DLTs.
a 28-day cycle
Number of Patients with Adverse events (AEs)
Time Frame: Screening through 30 days after last dose

Part 1 Frequency, duration, and severity (Common Terminology Criteria for Adverse Events [CTCAE] v5.0) of adverse events, dose limiting toxicity (DLT), physical examinations, changes in clinical laboratory values (e.g., hematology, chemistry, and urinalysis), vital signs (e.g., heart rate, blood pressure, respiratory rate), electrocardiogram

Adverse event: An AE is defined as any untoward medical occurrence in a clinical study patient administered a pharmaceutical product, and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of an IMP, whether it is considered related to the IMP.
Screening through 30 days after last dose

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-Free Survival (PFS)
Time Frame: From Cycle 1 Day 1 until the first documented objective disease progression or death due to any cause, whichever occurs first, up to approximately 3 years
Investigator Review according to RECIST v1.1 criteria
From Cycle 1 Day 1 until the first documented objective disease progression or death due to any cause, whichever occurs first, up to approximately 3 years
Overall Survival (OS)
Time Frame: From Cycle 1 Day 1 until Death, up to approximately 3 years
Investigator Review according to RECIST v1.1 criteria
From Cycle 1 Day 1 until Death, up to approximately 3 years
Cmax of MT-4561
Time Frame: Cycle 1 Day 1 through Cycle 2 Day 22 (each cycle is 28 days)
To determine the pharmacokinetics(PK) profile of MT-4561
Cycle 1 Day 1 through Cycle 2 Day 22 (each cycle is 28 days)
time corresponding to occurrence of Cmax (tmax)
Time Frame: Cycle 1 Day 1 through Cycle 2 Day 22 (each cycle is 28 days)
To determine the pharmacokinetics(PK) profile of MT-4561
Cycle 1 Day 1 through Cycle 2 Day 22 (each cycle is 28 days)
minimum observed plasma concentration (Cmin)
Time Frame: Cycle 1 Day 1 through Cycle 2 Day 22 (each cycle is 28 days)
To determine the pharmacokinetics(PK) profile of MT-4561
Cycle 1 Day 1 through Cycle 2 Day 22 (each cycle is 28 days)
area under the concentration-time curve from zero up to 168 hours post-dose (AUC0-168)
Time Frame: Cycle 1 Day 1 through Cycle 2 Day 22 (each cycle is 28 days)
To determine the pharmacokinetics(PK) profile of MT-4561
Cycle 1 Day 1 through Cycle 2 Day 22 (each cycle is 28 days)
Renal clearance (CL) after the first dose and at steady state
Time Frame: Cycle 1 Day 1 through Cycle 2 Day 22 (each cycle is 28 days)
To determine the pharmacokinetics(PK) profile of MT-4561
Cycle 1 Day 1 through Cycle 2 Day 22 (each cycle is 28 days)
dose proportionality
Time Frame: Cycle 1 Day 1 through Cycle 2 Day 22 (each cycle is 28 days)
To determine the pharmacokinetics(PK) profile of MT-4561
Cycle 1 Day 1 through Cycle 2 Day 22 (each cycle is 28 days)
accumulation ratio
Time Frame: Cycle 1 Day 1 through Cycle 2 Day 22 (each cycle is 28 days)
To determine the pharmacokinetics(PK) profile of MT-4561
Cycle 1 Day 1 through Cycle 2 Day 22 (each cycle is 28 days)
Objective Response Rate (ORR)
Time Frame: From Cycle 1 Day 1 until Progressive Disease/Death/or start of new anticancer therapy, up to approximately 3 years
ORR defined as the proportion of patients with a best overall response of complete response (CR) and partial response (PR) recorded from start of study intervention until the last objective response documented.
From Cycle 1 Day 1 until Progressive Disease/Death/or start of new anticancer therapy, up to approximately 3 years
Disease control rate (DCR)
Time Frame: From Cycle 1 Day 1 until Progressive Disease/Death/or start of new anticancer therapy, up to approximately 3 years
DCR defined as the proportion of patients with a best overall response of complete response (CR), partial response (PR), or stable disease (SD).
From Cycle 1 Day 1 until Progressive Disease/Death/or start of new anticancer therapy, up to approximately 3 years
Clinical benefit rate (CBR)
Time Frame: From Cycle 1 Day 1 until Progressive Disease/Death/or start of new anticancer therapy, up to approximately 3 years
CBR defined as the proportion of patients with best overall response of complete response (CR), partial response (PR), or who have had stable disease (SD) for a minimum of 6 months after the first dose of study intervention.
From Cycle 1 Day 1 until Progressive Disease/Death/or start of new anticancer therapy, up to approximately 3 years
Best overall response (BoR)
Time Frame: From Cycle 1 Day 1 until Progressive Disease/Death/or start of new anticancer therapy, up to approximately 3 years
BoR defined as the best response in the order of complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD) among all overall responses recorded from the start of the study intervention until the last objective response recorded.
From Cycle 1 Day 1 until Progressive Disease/Death/or start of new anticancer therapy, up to approximately 3 years
Duration of Response (DoR)
Time Frame: From Cycle 1 Day 1 until Progressive Disease/Death/or start of new anticancer therapy, up to approximately 3 years
Investigator Review according to RECIST v1.1 criteria
From Cycle 1 Day 1 until Progressive Disease/Death/or start of new anticancer therapy, up to approximately 3 years
Duration of stable disease (SD)
Time Frame: From Cycle 1 Day 1 until Progressive Disease/Death/or start of new anticancer therapy, up to approximately 3 years
Time from the date of the first dose of the study intervention to the first documented progressive disease (PD).
From Cycle 1 Day 1 until Progressive Disease/Death/or start of new anticancer therapy, up to approximately 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tanabe Pharma America, Inc.

Investigators

  • Study Director: Head of Medical Science, Tanabe Pharma America, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 18, 2025

Primary Completion (Estimated)

August 1, 2028

Study Completion (Estimated)

August 1, 2028

Study Registration Dates

First Submitted

March 28, 2025

First Submitted That Met QC Criteria

April 16, 2025

First Posted (Actual)

April 24, 2025

Study Record Updates

Last Update Posted (Actual)

December 11, 2025

Last Update Submitted That Met QC Criteria

December 4, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MT-4561-Z-101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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