Brief Title: MT-4561 in Patients With Various Advanced Solid Tumors

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Incidence of Adverse Event

Primary Outcome 1 - Timeframe: a 28-day cycle

Primary Outcome 2 - Measure: Dose limiting toxicities (DLTs)

Primary Outcome 2 - Timeframe: Screening through 30 days after last dose

Primary Outcome 3 - Measure: Number of Patients with Adverse events (AEs)

Primary Outcome 3 - Timeframe: N/A

CONDITION

• 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
• NUT Carcinoma

ELIGIBILITY

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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Head of Medical Science

Role: Study Director

Affiliation: Mitsubishi Tanabe Pharma America Inc.

Overall Contact

Name: Clinical Trials Information Desk, to prevent miscommunication,

Phone: Please E-mail

Email: [email protected]

LOCATION