Actively Recruiting
A Phase I/II Dose-escalation and Dose-optimization Study Evaluating Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of MT-4561 in Patients With Various Advanced Solid Tumors
Led by Tanabe Pharma America, Inc. · Updated on 2025-12-11
27
Participants Needed
6
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating MT-4561, an investigational drug, in adults with various advanced solid tumors including head and neck, lung, esophageal, gastric, biliary tract, pancreatic, breast, ovarian, cervical, endometrial, prostate, urothelial, neuroendocrine tumors, soft tissue sarcoma, and NUT carcinoma. This Phase I/II study aims to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and effectiveness of MT-4561 in patients who have exhausted other treatment options or cannot tolerate standard therapies. The study is sponsored by Tanabe Pharma America, Inc. The study is conducted in three parts. Part 1 focuses on finding the maximum tolerated dose using a dose-escalation design with weekly intravenous infusions of MT-4561 in 28-day cycles until disease progression or stopping criteria are met. Parts 2 and 3 will explore dose optimization and drug interactions after reviewing Part 1 results. Participants receive the study drug via intravenous infusion once a week during each 28-day cycle. Participants will be regularly monitored for side effects, dose-limiting toxicities, and drug levels in blood. Researchers will assess tumor response and disease control over approximately three years. Evaluations include physical exams, lab tests, and imaging to measure tumor changes, survival, and duration of disease stability. The study includes screening, treatment cycles, and follow-up visits to track safety and outcomes throughout the trial period.
CONDITIONS
Brief Title
A Study of MT-4561 in Patients With Various Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 years or older at informed consent
- Male or female patients
- Failed at least one prior therapy with no standard treatment options providing clinical benefit, or intolerant/refusing further standard therapies
- At least one measurable tumor lesion by RECIST v1.1
- ECOG performance status of 0 or 1
- Life expectancy of at least 3 months
- Adequate bone marrow function
- Adequate liver function
- Adequate kidney function with creatinine clearance ≥ 60 mL/min (Cockcroft and Gault or institutional method)
- Confirmed diagnosis of specified advanced solid tumors including head and neck, lung, esophageal, gastric, biliary tract, pancreatic, breast, ovarian, cervical, endometrial, prostate, urothelial carcinoma, neuroendocrine tumors, soft tissue sarcoma, or NUT carcinoma
You will not qualify if you...
- Active brain or leptomeningeal metastases
- Unresolved toxicity Grade 2 or higher from prior anticancer therapy except alopecia
- Systemic anticancer therapy within 4 weeks or 5 half-lives before first dose
- Radiotherapy within 2 weeks before first dose
- History of congenital long QT syndrome or significant ventricular arrhythmias
- Use of drugs known to prolong QT interval or cause Torsades de pointes within 14 days or 5 half-lives before study drug
- QTcF > 470 msec at screening
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 28-day cycles until disease progression or discontinuation.
Participants receive intravenous MT-4561 once every week in 28-day cycles until disease progression or discontinuation criteria are met.
Weekly visits for infusion
Duration - Up to approximately 3 years
Participants are monitored for safety, tolerability, and outcomes for up to approximately 3 years after starting treatment.
Visits as scheduled for assessments up to 3 years
Trial Site Locations
Total: 6 locations
1
University of Southern California
Los Angeles, California, United States, 90033
Actively Recruiting
2
START Midwest
Grand Rapids, Michigan, United States, 49546
Actively Recruiting
3
The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Actively Recruiting
4
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
5
National Cancer Center Hospital
Chuo-Ku, Tokyo, Japan, 104-0045
Actively Recruiting
6
National Cancer Center Hospital East
City, Japan
Actively Recruiting
Research Team
C
Clinical Trials Information Desk, to prevent miscommunication,
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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