NCT06943521

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

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

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 27 (estimated)
• Sponsor: Tanabe Pharma America, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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
• Pancreatic Ductal Adenocarcinoma (PDAC)
• 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

Interventions

Type	Name	Description
DRUG	MT-4561	i.v.

Timeline

• Start date: 2025-04-18
• Primary completion: 2028-08-01
• Completion: 2028-08-01
• First posted: 2025-04-24
• Last updated: 2025-12-11

Locations

6 sites across 2 countries: United States, Japan

Regulatory

• FDA-regulated drug study