RecruitingPhase 1Phase 2NCT06943521

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

Sponsor

Tanabe Pharma America, Inc.

Enrollment

27 participants

Start Date

Apr 18, 2025

Study Type

INTERVENTIONAL

Conditions

Breast Cancer Esophageal Cancer Gastric Cancer Head and Neck Squamous Cell Carcinoma (HNSCC)Non-small Cell Lung Cancer (NSCLC)Biliary Tract Cancer Pancreatic Ductal Adenocarcinoma (PDAC)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

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This Phase I dose-finding trial is testing MT-4561, a new experimental anticancer drug, in patients with a range of advanced solid tumors that have not responded to standard treatments. **You may be eligible if...** - You are 18 or older - You have an advanced solid tumor — including lung, head and neck, esophageal, gastric, breast, ovarian, cervical, prostate, bladder, pancreatic, or other cancers — that has failed at least one prior therapy and has no other standard treatment options - You have measurable disease on scans (RECIST 1.1) - Your performance status is good (ECOG 0–1) and your organ function is adequate - Your life expectancy is at least 3 months **You may NOT be eligible if...** - You have active brain metastases - You have had recent major surgery or radiation - You have severe organ impairment - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.