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NCT Number: NCT06943521

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, 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.

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Key information

Conditions

Head and Neck Squamous Cell Carcinoma (HNSCC) Adenocarcinoma Adnexal Diseases Biliary Tract Cancer Biliary Tract Diseases Biliary Tract Neoplasms Breast Cancer Breast Diseases Breast Neoplasms Bronchial Neoplasms Carcinoma Carcinoma, Bronchogenic Carcinoma, Neuroendocrine Carcinoma, Non-Small-Cell Lung Carcinoma, Squamous Cell Carcinoma, Transitional Cell Cervical Cancer Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Endometrial Cancer Endometrial Neoplasms Esophageal Cancer Esophageal Diseases Esophageal Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastric Cancer Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Female Genital Diseases, Male Genital Neoplasms, Female Genital Neoplasms, Male Gonadal Disorders Head and Neck Neoplasms Lung Diseases Lung Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Connective and Soft Tissue Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Carcinoma (NEC) Neuroendocrine Tumor (NET) Neuroendocrine Tumors Non-small Cell Lung Cancer (NSCLC) Nuclear Protein in Testis (NUT) Carcinoma Ovarian Cancer Ovarian Diseases Ovarian Neoplasms Pancreatic Ductal Adenocarcinoma (PDAC) Prostate Cancer Prostatic Diseases Prostatic Neoplasms Respiratory Tract Diseases Respiratory Tract Neoplasms Sarcoma Skin Diseases Skin and Connective Tissue Diseases Soft Tissue Sarcoma Squamous Cell Carcinoma of Head and Neck Stomach Diseases Stomach Neoplasms Thoracic Neoplasms Urogenital Diseases Urogenital Neoplasms Urothelial Carcinoma Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

National Cancer Center Hospital, Chuo-Ku, Tokyo, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MT-4561

Drug

i.v.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Cmax of MT-4561

    Time frame: Cycle 1 Day 1 through Cycle 2 Day 22 (each cycle is 28 days)

    To determine the pharmacokinetics(PK) profile of MT-4561

  2. time corresponding to occurrence of Cmax (tmax)

    Time frame: Cycle 1 Day 1 through Cycle 2 Day 22 (each cycle is 28 days)

    To determine the pharmacokinetics(PK) profile of MT-4561

  3. minimum observed plasma concentration (Cmin)

    Time frame: Cycle 1 Day 1 through Cycle 2 Day 22 (each cycle is 28 days)

    To determine the pharmacokinetics(PK) profile of MT-4561

  4. 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)

    To determine the pharmacokinetics(PK) profile of MT-4561

  5. 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)

    To determine the pharmacokinetics(PK) profile of MT-4561

  6. dose proportionality

    Time frame: Cycle 1 Day 1 through Cycle 2 Day 22 (each cycle is 28 days)

    To determine the pharmacokinetics(PK) profile of MT-4561

  7. accumulation ratio

    Time frame: Cycle 1 Day 1 through Cycle 2 Day 22 (each cycle is 28 days)

    To determine the pharmacokinetics(PK) profile of MT-4561

  8. 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

    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.

  9. 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

    DCR defined as the proportion of patients with a best overall response of complete response (CR), partial response (PR), or stable disease (SD).

  10. 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

    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.

  11. 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

    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.

  12. 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

    Investigator Review according to RECIST v1.1 criteria

  13. 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

    Investigator Review according to RECIST v1.1 criteria

  14. Overall Survival (OS)

    Time frame: From Cycle 1 Day 1 until Death, up to approximately 3 years

    Investigator Review according to RECIST v1.1 criteria

  15. 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

    Time from the date of the first dose of the study intervention to the first documented progressive disease (PD).

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Trials Information Desk, to prevent miscommunication,

CONTACT

[email protected]

Please E-mail

Sponsors and collaborators

Lead sponsor

Tanabe Pharma America, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Apr 24, 2025
Registry last updated
Dec 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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