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

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.

Trial Details

NCT ID
NCT06943521
Phase
PHASE1 / PHASE2
Sponsor
Tanabe Pharma America, Inc.
Status
RECRUITING
Cancer Type
Pancreatic Ductal Adenocarcinoma Pancreatic Cancer
Interventions
  • MT-4561
Locations (sample)
  • Los Angeles, California, United States|34.05223,-118.24368
  • Grand Rapids, Michigan, United States|42.96336,-85.66809
  • Columbus, Ohio, United States|39.96118,-82.99879
  • Houston, Texas, United States|29.76328,-95.36327
  • Chuo-Ku, Tokyo, Japan

Key Eligibility Criteria

  • Patients who have failed at least 1 prior therapy and, who have no standard treatment options demonstrated to provide clinical benefit or who are i…
  • 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
  • Eastern Cooperative Oncology Group (ECOG) performance status: 0 to 1

For full eligibility, visit ClinicalTrials.gov.

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