Evaluating MT-4561 in Patients with Advanced Solid Tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a First In Human (FIH), multicenter, open-label study designed to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of MT-4561 in patients with various advanced solid tumors. The study is divided into three parts, with Part 1 focusing on determining the Maximum Tolerated Dose (MTD) using a Bayesian Optimal Interval design. Subsequent parts will explore dose optimization and drug-drug interactions based on the results from Part 1.

Why it matters

Who can join: the full rules

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

Where it's running

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

Study contacts

• Study coordinator: Clinical Trials Information Desk, to prevent miscommunication,
• Email: information.US@mb.tanabe-pharma.com
• Phone: Please E-mail

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.