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New treatment option for Head and Neck Squamous Cell Carcinoma (HNSCC)
Official title A Study of MT-4561 in Patients With Various Advanced Solid Tumors
ClinicalTrials.gov ID: NCT06943521
What this study is testing
What is MT-4561?
MT-4561 is an investigational medicine, being studied as a potential treatment for head and neck squamous cell carcinoma (hnscc).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Main Patients who have failed at least 1 prior therapy and, who have no standard treatment options demonstrated to provide clinical benefit or who...
- 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
You likely can't join if
- 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...
- History of congenital long QT syndrome or clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation...
- 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...
- QT interval corrected for heart rate using Fridericia's correction (QTcF) \> 470 msec at screening
See the full eligibility criteria
- Main 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- Grand Rapids, Michigan, United States
- Columbus, Ohio, United States
- Houston, Texas, United States
- Chuo-Ku, Tokyo, Japan
- City, Japan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; Grand Rapids, Michigan, United States; Columbus, Ohio, United States; Houston, Texas, United States; Chuo-Ku, Tokyo, Japan; City, Japan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.