NCT06943521RecruitingPhase 1/2
A Study of MT-4561 in Patients With Various Advanced Solid Tumors
A Phase I/II, Dose-escalation and Dose-optimization Study to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of MT-4561 in Patients With Various Advanced Solid Tumors and to Evaluate Effect of MT-4561 on Pharmacokinetics of Oral Midazolam
Source: ClinicalTrials.gov · Last updated 11 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 27 (estimated)
- First submitted
- 28 Mar 2025
- Start date
- 18 Apr 2025
- Primary completion date
- Aug 2028
- Lead sponsor
- Tanabe Pharma America, Inc.
- Diseases
- Prostate cancer, Head and neck cancer, Neuroendocrine tumours, Bladder cancer, Endometrial cancer, Cervical cancer, Lung cancer, Pancreatic cancer, Liver and biliary tract cancer, Gastric and esophageal cancer, Ovarian cancer, Sarcoma
- NCT number
- NCT06943521
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 27
- From 18 Apr 2025 to the primary completion date, Aug 2028
- 6 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- Main Inclusion Criteria:
- Patients who have failed at least 1 prior therapy and, who have no standard treatment options demonstrated to provide clinical benefit or who are intolerable to or refuse further standard therapies will be enrolled.
- Male or female patient aged 18 years or older at the time of signing the informed consent form
- ≥ 1 measurable lesion by the RECIST v1.1
- Eastern Cooperative Oncology Group (ECOG) performance status: 0 to 1
- Life expectancy of at least 3 months
- Adequate bone marrow function
- Adequate hepatic function
- Adequate renal function estimated creatinine clearance ≥ 60 mL/min calculated using the Cockcroft and Gault equation or by institutional method
- Part 1: Patients must have a confirmed histologic or cytologic diagnosis of one of the following solid tumors for participation in the study: head and neck squamous cell carcinoma (HNSCC), non-small cell lung cancer (NSCLC), esophageal cancer, gastric cancer, biliary tract cancer, pancreatic ductal adenocarcinoma (PDAC), breast cancer, ovarian cancer, cervical cancer, endometrial cancer, prostate cancer, urothelial carcinoma, neuroendocrine tumor (NET) or neuroendocrine carcinoma (NEC), soft tissue sarcoma, and NUT carcinoma.
- Main Exclusion Criteria:
- Patients with active brain or leptomeningeal metastases
- Any unresolved toxicity ≥ Grade 2 from previous anticancer therapy except for alopecia
- Prior systemic anticancer therapy within 4 weeks before first dose of investigational medicinal product (IMP) or 5 half-lives, whichever is shorter, and prior radiotherapy within 2 weeks before first dose of IMP
- History of congenital long QT syndrome or clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation or Torsades de pointes)
- Patients who received drugs with a known risk of QT interval prolongation or Torsades de pointes within 14 days or 5 half-lives, whichever is shorter, before the start of IMP administration
- QT interval corrected for heart rate using Fridericia's correction (QTcF) \> 470 msec at screening
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| National Cancer Center Hospital Coordinator of this site? Confirm its status | Chuo Ku | Japan | Recruiting |
| National Cancer Center Hospital East Coordinator of this site? Confirm its status | City | Japan | Recruiting |
| The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer Center Coordinator of this site? Confirm its status | Columbus | United States | Recruiting |
| START | Midwest Coordinator of this site? Confirm its status | Grand Rapids | United States | Recruiting |
| The University of Texas MD Anderson Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
| University of Southern California Coordinator of this site? Confirm its status | Los Angeles | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.