Study on MT-4561 for Patients with Advanced Solid Tumors
Sponsor: Mitsubishi Tanabe Pharma America Inc.
ClinicalTrials ID:NCT06943521
This clinical trial is testing a new drug, MT-4561, to see if it is safe and effective for treating various advanced solid tumors. The study is divided into three parts, starting with determining the safest dose.
Patient Parameters
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Program Overview
This study is the first to test MT-4561 in humans and involves multiple centers. It aims to evaluate the safety, how the body processes the drug, and its effectiveness in treating advanced solid tumors. The study is conducted in three parts. Part 1 focuses on finding the safest dose of MT-4561. Parts 2 and 3 will explore the best dose and how MT-4561 interacts with other drugs, based on the results from Part 1.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older.
- Have at least one tumor that can be measured and one site for a biopsy.
- Be in good general health, able to carry out normal activities or light work.
- Have a life expectancy of at least 3 months.
- Have good bone marrow, liver, and kidney function.
- For Part 1, must have a confirmed diagnosis of one of the following cancers: head and neck, lung, esophageal, stomach, bile duct, pancreatic, breast, ovarian, cervical, endometrial, prostate, bladder, neuroendocrine, soft tissue sarcoma, or NUT carcinoma.
Exclusion Criteria
- Have active cancer spread to the brain or spinal fluid.
- Have unresolved side effects from previous cancer treatments, except for hair loss.
- Have had cancer treatment within 4 weeks before starting the study drug.
- Have a history of certain heart rhythm problems.
- Have taken drugs that affect heart rhythm within 14 days before starting the study drug.
- Have a specific heart rhythm measurement (QTcF) greater than 470 milliseconds at screening.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| START Midwest | 49546 | Grand Rapids | Michigan |
| The University of Texas MD Anderson Cancer Center | 77030 | Houston | Texas |
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