Health Trials

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

ConditionsHead and Neck Squamous Cell Carcinoma (HNSCC)Non-small Cell Lung Cancer (NSCLC)Esophageal CancerGastric CancerBiliary Tract CancerPancreatic Ductal Adenocarcinoma (PDAC)Breast CancerOvarian CancerCervical CancerEndometrial CancerProstate CancerUrothelial CarcinomaNeuroendocrine Tumor (NET)Neuroendocrine Carcinoma (NEC)Soft Tissue SarcomaNuclear Protein in Testis (NUT) Carcinoma
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorTanabe Pharma America, Inc.

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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)

Trial design

Treatments tested in this trial

  • MT-4561

Treatment groups

27 Participants
are divided into 1 treatment group

Sponsors and collaborators

Tanabe Pharma America, Inc.

Lead sponsor

Source ClinicalTrials.gov