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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

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Trial Profile

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 of Trial: Phase I/II

Latest Information Update: 22 Jul 2025

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At a glance

  • Drugs MT 4561 (Primary) ; Midazolam
  • Indications Adenocarcinoma; Biliary cancer; Breast cancer; Cervical cancer; Endometrial cancer; Gastric cancer; Head and neck cancer; Male breast cancer; Neuroendocrine carcinoma; Neuroendocrine tumours; Non-small cell lung cancer; Oesophageal cancer; Ovarian cancer; Pancreatic ductal carcinoma; Prostate cancer; Soft tissue sarcoma; Solid tumours; Squamous cell cancer; Testicular cancer; Urogenital cancer
  • Focus Adverse reactions; First in man
  • Sponsors Mitsubishi Tanabe Pharma America

Most Recent Events

  • 12 Jun 2025 According to Mitsubishi Tanabe Pharma America media release, the first patient dosing was done at START Midwest, one of the sites for the study. This trial will be conducted in 3 parts, across several sites, with 1st part evaluating adverse events and DLTs, and details and doses of Part 2 (dose-optimization) and Part 3 (Drug-Drug Interaction) will be available after review of applicable Part 1 results.
  • 12 Jun 2025 According to Mitsubishi Tanabe Pharma America media release, the first patient was dosed in this trial in May.
  • 18 May 2025 Status changed from not yet recruiting to recruiting.

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