Study of MT-4561 for Advanced Solid Tumors
This study is testing a new drug called MT-4561 for people with advanced solid tumors, including head and neck, lung, esophageal, gastric, and biliary tract cancers. You might be able to join if you are 18 or older, have tried at least one other treatment, and have no other standard options or cannot tolerate them. The main goals are to see how safe MT-4561 is, what side effects it causes, and to find the right dose. This is a "First In Human" study, meaning it's one of the first times this drug is being tested in people. The study plans to enroll 27 participants.
- Study design
- This is a Phase I/II, open-label study, meaning both you and your doctors will know you are receiving MT-4561. It is designed to evaluate the drug in approximately 27 participants.
- What's involved
- The study will track side effects from screening through 30 days after your last dose of MT-4561, which is given intravenously (i.v.).
- Compensation
- Not stated in the trial record.
- Follow-up
- You will be followed for adverse events (side effects) from screening through 30 days after your last dose of MT-4561.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
A Study of MT-4561 in Patients With Various Advanced Solid Tumors
At a glance
Conditions
Where it's being run
6 sites across 6 statesStudy leadership
- Head of Medical Science · STUDY_DIRECTOR · Tanabe Pharma America, Inc.
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Incidence of Adverse Event, Dose limiting toxicities (DLTs)a 28-day cycle
Part 1 Frequency, duration, and severity (Common Terminology Criteria for Adverse Events \[CTCAE\] v5.0) of adverse events, dose limiting toxicity (DLT), physical examinations, changes in clinical laboratory values (e.g., hematology, chemistry, and urinalysis), vital signs (e.g., heart rate, blood pressure, respiratory rate), electrocardiogram DLTs are defined as any event meeting the DLT criteria at least possibly related to MT-4561 for Cycle 1 (i.e., DLT monitoring window is approximately 28 days). Events with a clear alternative explanation will not be considered DLTs.
- Number of Patients with Adverse events (AEs)Screening through 30 days after last dose
Part 1 Frequency, duration, and severity (Common Terminology Criteria for Adverse Events \[CTCAE\] v5.0) of adverse events, dose limiting toxicity (DLT), physical examinations, changes in clinical laboratory values (e.g., hematology, chemistry, and urinalysis), vital signs (e.g., heart rate, blood pressure, respiratory rate), electrocardiogram Adverse event: An AE is defined as any untoward medical occurrence in a clinical study patient administered a pharmaceutical product, and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of an IMP, whether it is considered related to the IMP.