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

Launched by MITSUBISHI TANABE PHARMA AMERICA INC. · Apr 16, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called MT-4561 to see how safe and effective it is for patients with various advanced solid tumors, such as head and neck cancer, lung cancer, breast cancer, and several others. The trial is in its early stages and will involve three parts. The first part focuses on finding out the safest dose of MT-4561, understanding how the body processes the drug, and assessing how it affects tumors.

To be eligible for this study, participants must be at least 18 years old and have one of the specific types of cancer mentioned. They should also have a measurable tumor and a good overall health status, meaning they can perform daily activities with little difficulty. However, patients with certain conditions, such as active brain tumors or severe heart issues, cannot participate. Those who join the trial can expect close monitoring and support from the medical team throughout the study. It's important to note that this trial is not yet recruiting participants, so anyone interested will need to wait until it opens.

Gender

ALL

Eligibility criteria

• Main Inclusion Criteria:
• • 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 and ≥ 1 disease site for tumor biopsy
• • Eastern Cooperative Oncology Group 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 longer, before the start of IMP administration
• • QT interval corrected for heart rate using Fridericia's correction (QTcF) \> 470 msec at screening