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OncoMatch/Clinical Trials/NCT06943521

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

Is NCT06943521 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies MT-4561 for head and neck squamous cell carcinoma (hnscc).

Phase 1/2RecruitingTanabe Pharma America, Inc.NCT06943521Data as of May 2026

Treatment: MT-4561 — 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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Extracted eligibility criteria

Cancer type

Head and Neck Squamous Cell Carcinoma

Non-Small Cell Lung Carcinoma

Esophageal Carcinoma

Gastric Cancer

Cholangiocarcinoma

Pancreatic Cancer

Breast Carcinoma

Ovarian Cancer

Cervical Cancer

Endometrial Cancer

Prostate Cancer

Urothelial Carcinoma

Neuroendocrine Tumor

Sarcoma

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Min 1 prior line

Lab requirements

Blood counts

Adequate bone marrow function

Kidney function

Adequate renal function estimated creatinine clearance ≥ 60 mL/min calculated using the Cockcroft and Gault equation or by institutional method

Liver function

Adequate hepatic function

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

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • University of Southern California · Los Angeles, California
  • START Midwest · Grand Rapids, Michigan
  • The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer Center · Columbus, Ohio
  • The University of Texas MD Anderson Cancer Center · Houston, Texas

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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