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A Study of MT-4561 in Patients With Various Advanced Solid Tumors
NCT06943521 · View on ClinicalTrials.gov ↗
Study 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 solid tumors. This study will be conducted in 3 parts. Part 1 is aimed at evaluating safety, tolerability, PK and pharmacodynamics of MT-4561 and determining the Maximum Tolerated Dose (MTD) using the Bayesian Optimal Interval (BOIN) design. The study details and doses of Part 2 (dose-optimization) and Part 3 (Drug-Drug Interaction) will be available after review of applicable Part 1 results.
Conditions Studied
Interventions
- DRUG MT-4561
Study Locations (6)
California
- University of Southern California — Los Angeles
Michigan
- START Midwest — Grand Rapids
Ohio
- The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer Center — Columbus
Texas
- The University of Texas MD Anderson Cancer Center — Houston
Tokyo
- National Cancer Center Hospital — Chuo-Ku
Other
- National Cancer Center Hospital East — City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2025-04-18 |
| Est. Completion | 2028-08 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06943521
The ClinicalTrials.gov registry entry for NCT06943521 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 27 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Tanabe Pharma America, which has 38 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 10 conditions, with Breast Cancer appearing as the primary indexed condition, and to 1 intervention — of which MT-4561 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06943521 reports 6 study locations spanning 6 distinct geographic areas — top geographies include California, Michigan, Ohio. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06943521 about?
NCT06943521 is a clinical study titled "A Study of MT-4561 in Patients With Various Advanced Solid Tumors". 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 solid tumors. This study will be conducted in 3 parts. Part 1 is aimed at evaluating safety, tolerab...
What is the current status of trial NCT06943521?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 27 participants. The study started on 2025-04-18. Estimated completion is 2028-08.
What conditions does trial NCT06943521 study?
This clinical trial studies the following conditions: Breast Cancer, Ovarian Cancer, Endometrial Cancer, Gastric Cancer, Cervical Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06943521?
The interventions under investigation include: MT-4561 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06943521?
This trial is sponsored by Tanabe Pharma America, which has 38 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06943521 being conducted?
This trial has 6 study locations across California, Michigan, Ohio, Texas, Tokyo. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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