Recruiting
Phase 1
Phase 2

MT-4561

Sponsor:

Tanabe Pharma America, Inc.

Code:

NCT06943521

Conditions

Head and Neck Squamous Cell Carcinoma (HNSCC)

Non-small Cell Lung Cancer (NSCLC)

Esophageal Cancer

Gastric Cancer

Biliary Tract Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

MT-4561

Study Details

Brief 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.

Conditions

Head and Neck Squamous Cell Carcinoma (HNSCC)

Non-small Cell Lung Cancer (NSCLC)

Esophageal Cancer

Gastric Cancer

Biliary Tract Cancer

Study ID

NCT06943521

Start date

Apr 18, 2025

Status verified date

Dec, 2025

Completion date

Aug, 2028

Anticipated

Primary completion date

Aug, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

27 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

MT-4561

i.v.

Primary outcome measure

  • Incidence of Adverse Event, Dose limiting toxicities (DLTs) [ Time Frame: a 28-day cycle ]
  • Number of Patients with Adverse events (AEs) [ Time Frame: Screening through 30 days after last dose ]

Central Contacts and Locations

Central contacts

Clinical Trials Information Desk, to prevent miscommunication,

Please E-mailinformation.US@mb.tanabe-pharma.com

Locations

University of Southern California

Recruiting

Los Angeles, California, United States, 90033

START Midwest

Recruiting

Grand Rapids, Michigan, United States, 49546

The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer Center

Recruiting

Columbus, Ohio, United States, 43210

The University of Texas MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

More Information

Sponsor

Tanabe Pharma America, Inc.

Last update posted

Dec 11, 2025

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Tanabe Pharma America, Inc. on 2025-12-11.