Clinical Trial

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

Recruiting Phase 1/2

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.

Protocol Amendment History 6 amendments

This ClinicalTrials.gov record has been amended 6 times since 2025-04-16; most recent amendment 2025-12-04.

Status change: Not Yet Recruiting → Recruiting 2025-05-14

Trial Details

NCT Number	NCT06943521
Lead Sponsor	Tanabe Pharma America, Inc.
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), Breast Cancer, Ovarian Cancer +8 more
Enrollment	27 participants
Start Date	2025-04-18
Primary Completion	2028-08 (estimated)
Study Completion	2028-08 (estimated)
Updated on ClinicalTrials.gov	2025-12-11