NCT06943521 A Study of MT-4561 in Patients With Various Advanced Solid Tumors
| NCT ID | NCT06943521 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Tanabe Pharma America, Inc. |
| Condition | Head and Neck Squamous Cell Carcinoma (HNSCC) |
| Study Type | INTERVENTIONAL |
| Enrollment | 27 participants |
| Start Date | 2025-04-18 |
| Primary Completion | 2028-08 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 27 participants in total. It began in 2025-04-18 with a primary completion date of 2028-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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
Contact & Investigator
Clinical Trials Information Desk, to prevent miscommunication,
✉ information.US@mb.tanabe-pharma.com📞 Please E-mail
Head of Medical Science
STUDY DIRECTOR
Tanabe Pharma America, Inc.
Frequently Asked Questions
Who can join the NCT06943521 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Head and Neck Squamous Cell Carcinoma (HNSCC). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06943521 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06943521 currently recruiting?
Yes, NCT06943521 is actively recruiting participants. Contact the research team at information.US@mb.tanabe-pharma.com for enrollment information.
Where is the NCT06943521 trial being conducted?
This trial is being conducted at Los Angeles, United States, Grand Rapids, United States, Columbus, United States, Houston, United States and 2 additional locations.
Who is sponsoring the NCT06943521 clinical trial?
NCT06943521 is sponsored by Tanabe Pharma America, Inc.. The principal investigator is Head of Medical Science at Tanabe Pharma America, Inc.. The trial plans to enroll 27 participants.