Head and Neck Squamous Cell Carcinoma (HNSCC)Phase 1/2NCT06943521
A Study of MT-4561 in Patients With Various Advanced Solid Tumors
A Phase 1/2 study testing MT-4561 in people with Head and Neck Squamous Cell Carcinoma (HNSCC) and Non-small Cell Lung Cancer (NSCLC), run by Tanabe Pharma America, Inc. at 6 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Squamous Cell Carcinoma (HNSCC), Non-small Cell Lung Cancer (NSCLC), Esophageal Cancer
- What is being tested?
- MT-4561
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 18 Apr 2025to Aug 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
6 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
Clinical Trials Information Desk, to prevent miscommunication, contact
6 sites in 2 countries
United States4 sites, 4 recruiting
- Recruiting
The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
- Recruiting
START Midwest
Grand Rapids, Michigan, 49546
- Recruiting
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
- Recruiting
University of Southern California
Los Angeles, California, 90033
Japan2 sites, 2 recruiting
- Recruiting
National Cancer Center Hospital
Chuo-Ku, Tokyo, 104-0045
- Recruiting
National Cancer Center Hospital East
City
About this study
Official title: 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
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
- Head and Neck Squamous Cell Carcinoma (HNSCC), Non-small Cell Lung Cancer (NSCLC), Esophageal Cancer, Gastric Cancer, Biliary Tract Cancer, Pancreatic Ductal Adenocarcinoma (PDAC)
- Being tested
- MT-4561
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck, Carcinoma, Non-Small-Cell Lung, Esophageal Neoplasms, Stomach Neoplasms, Biliary Tract Neoplasms, Breast Neoplasms, Ovarian Neoplasms, Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MT-4561Drug
i.v.
| Study group | Role | What they receive |
|---|---|---|
| Part 1 (Dose-escalation) | Experimental | Intravenous (IV) infusion of MT-4561 once every week in 28-day cycle, until disease progression or discontinuation criteria are met. Receives: Drug: MT-4561 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Event, Dose limiting toxicities (DLTs)
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 days). Events with a clear alternative explanation will not be considered DLTs.
Measured: a 28-day cycle
Number of Patients with Adverse events (AEs)
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
Adverse event: An AE is defined as any untoward medical occurrence in a clinical study patient administered a pharmaceutical product, and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of an IMP, whether it is considered related to the IMP.
Measured: Screening through 30 days after last dose
Secondary outcomes (15)
Cmax of MT-4561
To determine the pharmacokinetics(PK) profile of MT-4561
Measured: Cycle 1 Day 1 through Cycle 2 Day 22 (each cycle is 28 days)
time corresponding to occurrence of Cmax (tmax)
To determine the pharmacokinetics(PK) profile of MT-4561
Measured: Cycle 1 Day 1 through Cycle 2 Day 22 (each cycle is 28 days)
minimum observed plasma concentration (Cmin)
To determine the pharmacokinetics(PK) profile of MT-4561
Measured: Cycle 1 Day 1 through Cycle 2 Day 22 (each cycle is 28 days)
area under the concentration-time curve from zero up to 168 hours post-dose (AUC0-168)
To determine the pharmacokinetics(PK) profile of MT-4561
Measured: Cycle 1 Day 1 through Cycle 2 Day 22 (each cycle is 28 days)
Renal clearance (CL) after the first dose and at steady state
To determine the pharmacokinetics(PK) profile of MT-4561
Measured: Cycle 1 Day 1 through Cycle 2 Day 22 (each cycle is 28 days)
dose proportionality
To determine the pharmacokinetics(PK) profile of MT-4561
Measured: Cycle 1 Day 1 through Cycle 2 Day 22 (each cycle is 28 days)
accumulation ratio
To determine the pharmacokinetics(PK) profile of MT-4561
Measured: Cycle 1 Day 1 through Cycle 2 Day 22 (each cycle is 28 days)
Objective Response Rate (ORR)
ORR defined as the proportion of patients with a best overall response of complete response (CR) and partial response (PR) recorded from start of study intervention until the last objective response documented.
Measured: From Cycle 1 Day 1 until Progressive Disease/Death/or start of new anticancer therapy, up to approximately 3 years
Disease control rate (DCR)
DCR defined as the proportion of patients with a best overall response of complete response (CR), partial response (PR), or stable disease (SD).
Measured: From Cycle 1 Day 1 until Progressive Disease/Death/or start of new anticancer therapy, up to approximately 3 years
Clinical benefit rate (CBR)
CBR defined as the proportion of patients with best overall response of complete response (CR), partial response (PR), or who have had stable disease (SD) for a minimum of 6 months after the first dose of study intervention.
Measured: From Cycle 1 Day 1 until Progressive Disease/Death/or start of new anticancer therapy, up to approximately 3 years
Best overall response (BoR)
BoR defined as the best response in the order of complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD) among all overall responses recorded from the start of the study intervention until the last objective response recorded.
Measured: From Cycle 1 Day 1 until Progressive Disease/Death/or start of new anticancer therapy, up to approximately 3 years
Duration of Response (DoR)
Investigator Review according to RECIST v1.1 criteria
Measured: From Cycle 1 Day 1 until Progressive Disease/Death/or start of new anticancer therapy, up to approximately 3 years
Progression-Free Survival (PFS)
Investigator Review according to RECIST v1.1 criteria
Measured: From Cycle 1 Day 1 until the first documented objective disease progression or death due to any cause, whichever occurs first, up to approximately 3 years
Overall Survival (OS)
Investigator Review according to RECIST v1.1 criteria
Measured: From Cycle 1 Day 1 until Death, up to approximately 3 years
Duration of stable disease (SD)
Time from the date of the first dose of the study intervention to the first documented progressive disease (PD).
Measured: From Cycle 1 Day 1 until Progressive Disease/Death/or start of new anticancer therapy, up to approximately 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2025
- Study start18 Apr 2025
- Primary completionAug 2028 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck Squamous Cell Carcinoma (HNSCC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanabe Pharma America, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Head of Medical Science, Study director, Tanabe Pharma America, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06943521
- Sponsor's protocol ID
- MT-4561-Z-101
- Status last verified
- Dec 2025
- First submitted
- 28 Mar 2025
- Last updated
- 11 Dec 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06943521
- Acronym / sponsor ID
- MT-4561-Z-101
- Conditions
- Head and Neck Squamous Cell Carcinoma (HNSCC), Non-small Cell Lung Cancer (NSCLC), Esophageal Cancer, Gastric Cancer, Biliary Tract Cancer, Pancreatic Ductal Adenocarcinoma (PDAC)
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- Tanabe Pharma America, Inc.Industry (pharma, biotech, devices)
- Study start
- 18 Apr 2025 (actual)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 24 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Part 1 (Dose-escalation) | Experimental | Drug: MT-4561Intravenous (IV) infusion of MT-4561 once every week in 28-day cycle, until disease progression or discontinuation criteria are met. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MT-4561i.v. | Drug | Part 1 (Dose-escalation) |
Primary outcome
Incidence of Adverse Event, Dose limiting toxicities (DLTs)
Time frame: a 28-day cycle
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 days). Events with a clear alternative explanation will not be considered DLTs.
Number of Patients with Adverse events (AEs)
Time frame: Screening through 30 days after last dose
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 Adverse event: An AE is defined as any untoward medical occurrence in a clinical study patient administered a pharmaceutical product, and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of an IMP, whether it is considered related to the IMP.
15 secondary outcomes
Cmax of MT-4561
Time frame: Cycle 1 Day 1 through Cycle 2 Day 22 (each cycle is 28 days)
time corresponding to occurrence of Cmax (tmax)
Time frame: Cycle 1 Day 1 through Cycle 2 Day 22 (each cycle is 28 days)
minimum observed plasma concentration (Cmin)
Time frame: Cycle 1 Day 1 through Cycle 2 Day 22 (each cycle is 28 days)
area under the concentration-time curve from zero up to 168 hours post-dose (AUC0-168)
Time frame: Cycle 1 Day 1 through Cycle 2 Day 22 (each cycle is 28 days)
Renal clearance (CL) after the first dose and at steady state
Time frame: Cycle 1 Day 1 through Cycle 2 Day 22 (each cycle is 28 days)
dose proportionality
Time frame: Cycle 1 Day 1 through Cycle 2 Day 22 (each cycle is 28 days)
accumulation ratio
Time frame: Cycle 1 Day 1 through Cycle 2 Day 22 (each cycle is 28 days)
Objective Response Rate (ORR)
Time frame: From Cycle 1 Day 1 until Progressive Disease/Death/or start of new anticancer therapy, up to approximately 3 years
Disease control rate (DCR)
Time frame: From Cycle 1 Day 1 until Progressive Disease/Death/or start of new anticancer therapy, up to approximately 3 years
Clinical benefit rate (CBR)
Time frame: From Cycle 1 Day 1 until Progressive Disease/Death/or start of new anticancer therapy, up to approximately 3 years
Best overall response (BoR)
Time frame: From Cycle 1 Day 1 until Progressive Disease/Death/or start of new anticancer therapy, up to approximately 3 years
Duration of Response (DoR)
Time frame: From Cycle 1 Day 1 until Progressive Disease/Death/or start of new anticancer therapy, up to approximately 3 years
Progression-Free Survival (PFS)
Time frame: From Cycle 1 Day 1 until the first documented objective disease progression or death due to any cause, whichever occurs first, up to approximately 3 years
Overall Survival (OS)
Time frame: From Cycle 1 Day 1 until Death, up to approximately 3 years
Duration of stable disease (SD)
Time frame: From Cycle 1 Day 1 until Progressive Disease/Death/or start of new anticancer therapy, up to approximately 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Clinical Trials Information Desk, to prevent miscommunication, contact
Head of Medical Science study director
Tanabe Pharma America, Inc.
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing MT-4561 in people with Head and Neck Squamous Cell Carcinoma (HNSCC) and Non-small Cell Lung Cancer (NSCLC), run by Tanabe Pharma America, Inc. at 6 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trials Information Desk, to prevent miscommunication, (Please E-mail, information.US@mb.tanabe-pharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Adverse Event, Dose limiting toxicities (DLTs) (time frame: a 28-day cycle). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2025.