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NCT06943521 · ClinicalTrials.gov registry record · Phase 1
A Study of MT-4561 in Patients With Various Advanced Solid Tumors
A Phase 1 study of Breast Cancer and Ovarian Cancer, sponsored by Tanabe Pharma America.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 27
- Enrollment target
- 6
- Study locations
NCT06943521: Recruiting Phase 1 study of Breast Cancer and Ovarian Cancer, sponsored by Tanabe Pharma America.
NCT06943521 is a Phase 1 study of Breast Cancer and Ovarian Cancer that is actively recruiting participants, run by Tanabe Pharma America. The registered enrollment target is 27 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (99% lower). The trial reports 6 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06943521, a Phase 1 study of Breast Cancer and Ovarian Cancer, is actively recruiting participants, sponsored by Tanabe Pharma America.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 27 participants
- Enrollment target
- 6
- Study locations
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.
Primary Outcome
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
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 |
What NCT06943521 shows while recruiting
NCT06943521 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (99% lower).
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.
NCT06943521 lists 6 locations in 6 states (California, Michigan, Ohio).
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.
What interventions are being tested in trial NCT06943521?
The interventions under investigation include: MT-4561 (DRUG).
Who is sponsoring clinical trial NCT06943521?
This trial is sponsored by Tanabe Pharma America, which has 18 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Where NCT06943521's enrollment target sits among peer trials
27 1019th of 1224 higher than 198 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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