Status:
RECRUITING
A Study of MT-4561 in Patients With Various Advanced Solid Tumors
Lead Sponsor:
Tanabe Pharma America, Inc.
Conditions:
Head and Neck Squamous Cell Carcinoma (HNSCC)
Non-small Cell Lung Cancer (NSCLC)
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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 s...
Eligibility Criteria
Inclusion
- Main
- 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
- 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
Key Trial Info
Start Date :
April 18 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2028
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT06943521
Start Date
April 18 2025
End Date
August 1 2028
Last Update
December 11 2025
Active Locations (6)
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1
University of Southern California
Los Angeles, California, United States, 90033
2
START Midwest
Grand Rapids, Michigan, United States, 49546
3
The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
4
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030