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
Tanabe Pharma America, Inc.
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
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Main Inclusion 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 intolerable to or refuse further standard therapies will be enrolled. * 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 * Life expectancy of at least 3 months * Adequate bone marrow function * Adequate hepatic function * Adequate renal function estimated creatinine…
Interventions
- DrugMT-4561
i.v.
Locations (6)
- University of Southern CaliforniaLos Angeles, California
- START MidwestGrand Rapids, Michigan
- The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer CenterColumbus, Ohio
- The University of Texas MD Anderson Cancer CenterHouston, Texas
- National Cancer Center HospitalChuo-Ku, Tokyo
- National Cancer Center Hospital EastCity