Evaluating MT-4561 in Patients with Advanced Solid Tumors
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 study is testing a new drug called MT-4561 to see if it is safe and effective for people with advanced solid tumors.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 27 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Tanabe Pharma America, Inc. Industry-sponsored |
| Locations | 6 sites (Los Angeles, California and 5 other locations) |
| Trial ID | NCT06943521 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with measurable lesions from specific advanced solid tumors such as HNSCC, NSCLC, and others.
Not a fit: Patients with solid tumors not specified in the eligibility criteria or those with significant comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option for patients with advanced solid tumors.
How similar studies have performed: Other studies have shown promise with similar investigational approaches, but this specific treatment is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Los Angeles, California and 5 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.