Purpose

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 1/Phase 2
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Part 1 (Dose-escalation)
Intravenous (IV) infusion of MT-4561 once every week in 28-day cycle, until disease progression or discontinuation criteria are met.
  • Drug: MT-4561
    i.v.

Recruiting Locations

University of Southern California
Los Angeles 5368361, California 5332921 90033

START Midwest
Grand Rapids 4994358, Michigan 5001836 49546

The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer Center
Columbus 4509177, Ohio 5165418 43210

The University of Texas MD Anderson Cancer Center
Houston 4699066, Texas 4736286 77030

More Details

Status
Recruiting
Sponsor
Tanabe Pharma America, Inc.

Study Contact

Clinical Trials Information Desk, to prevent miscommunication,
Please E-mail
information.US@mb.tanabe-pharma.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.