A Study of MT-4561 in Patients With Various Advanced Solid Tumors

NCT06943521 | Recruiting Phase 1 FDA Drug

• 1 other identifier: MT-4561-Z-101
• Study Type: interventional
• Target: 27
• Locations: 2 countries
• Sites: 6

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.

Conditions

Head and Neck Squamous Cell Carcinoma (HNSCC); Non-small Cell Lung Cancer (NSCLC); Esophageal Cancer; Gastric Cancer; Biliary Tract Cancer; Breast Cancer; Ovarian Cancer; Cervical Cancer; Endometrial Cancer; Prostate Cancer; Urothelial Carcinoma; Neuroendocrine Tumor (NET); Neuroendocrine Carcinoma (NEC); Soft Tissue Sarcoma; Nuclear Protein in Testis (NUT) Carcinoma; Pancreatic Ductal Adenocarcinoma (PDAC)

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Screening through 30 days after last dose

Secondary Outcomes (15)

• Cmax of MT-4561

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

• time corresponding to occurrence of Cmax (tmax)

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

• minimum observed plasma concentration (Cmin)

  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)

  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

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

Study Arms (1)

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.

Drug: MT-4561

Interventions

MT-4561 DRUG

i.v.

Part 1 (Dose-escalation)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify 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, 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

Sponsors & Collaborators

• Tanabe Pharma America, Inc.: lead

Study Sites (6)

University of Southern California

Los Angeles, California, 90033, United States

RECRUITING

START Midwest

Grand Rapids, Michigan, 49546, United States

RECRUITING

The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

RECRUITING

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

National Cancer Center Hospital

Chuo-Ku, Tokyo, 104-0045, Japan

RECRUITING

National Cancer Center Hospital East

City, Japan

RECRUITING

MeSH Terms

Conditions

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; Endometrial Neoplasms; Prostatic Neoplasms; Carcinoma, Transitional Cell; Neuroendocrine Tumors; Carcinoma, Neuroendocrine; Sarcoma; Carcinoma

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Stomach Diseases; Biliary Tract Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Uterine Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Neoplasms, Male; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Adenocarcinoma; Neoplasms, Connective and Soft Tissue

Study Officials

• Head of Medical Science

  Tanabe Pharma America, Inc.

  STUDY DIRECTOR

Central Study Contacts

Clinical Trials Information Desk, to prevent miscommunication,

CONTACT

Please E-mail; information.US@mb.tanabe-pharma.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2025
• First Posted: April 24, 2025
• Study Start: April 18, 2025
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): August 1, 2028
• Last Updated: December 11, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (4); JP (2)