Spots Global Cancer Trial Database for Study of MT-6402 in Subjects With Advanced Solid Cancer That Expresses PD-L1
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Trial Identification
Brief Title: Study of MT-6402 in Subjects With Advanced Solid Cancer That Expresses PD-L1
Official Title: A Phase 1 Open-label, Multicenter, Dose-ranging Study to Investigate Safety and Tolerability, Efficacy, Pharmacokinetics, Pharmacodynamics and Immunogenicity of MT-6402 in Subjects With Advanced Solid Cancer That Expresses PD-L1
Study ID: NCT04795713
Interventions
Study Description
Brief Summary: This will be a Phase 1 Open-label, dose escalation and expansion study of MT-6402 (an Engineered Toxin Body (ETB)) in subjects with advanced solid cancer that expresses PD-L1
Detailed Description: This study will be conducted in two sequential parts: * Part 1 (Dose Escalation): The purpose of Part 1 is to evaluate the safety and tolerability of MT-6402 in subjects with advanced cancer (solid tumors) and to estimate the maximum tolerated dose (MTD) * Part 2 (Dose Expansion): The purpose of Part 2 is to confirm the recommended Phase 2 dose (RP2D) and to evaluate the efficacy of MT-6402 in subjects with advanced cancer. Part 2 will include subjects with PD-L1 positive non-small cell lung cancer (NSCLC) who received prior PD-1/PD-L1 treatment, subjects with PD-L1 positive squamous cell cancer of the head and neck (SCCHN) who are refractory to or ineligible for platinum-based therapy and received prior PD-1/PD-L1 treatment and subjects with any other relapsed or refractory PD-L1 positive solid tumor who received PD-1/PD-L1 treatment. Up to 138 eligible subjects will be identified and treated through competitive enrollment at multiple study centers In Parts 1 and 2, a subject may participate for the following four (4) periods: * Screening Period - up to 28 days before first dose of MT-6402 * Treatment Period - active period where a subject will receive doses of MT-6402 over a 28-day treatment period * Short-term Follow-up Period - up to 90 days after last dose of MT-6402 * Long-term follow-up Period - up to 24 months after last dose of MT-6402 MT-6402 will be given as an intravenous (IV) infusion over 30 minutes on the same day every week (i.e., days 1, 8, 15 and 22) of each cycle. A cycle is defined as 28 days. A subject can continue receiving MT-6402 as long as it is well-tolerated or until the subject decides they no longer want to participate in the study.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
City of Hope Medical Center, Duarte, California, United States
USC Medical Center, Los Angeles, California, United States
Cedars Sinai Medical Center, Los Angeles, California, United States
Comprehensive Care and Research Center - Atlanta, Newnan, Georgia, United States
Comprehensive Care and Research Center - Chicago, Chicago, Illinois, United States
University of Louisville Health - Brown Cancer Center, Louisville, Kentucky, United States
Washington University School of Medicine - St. Louis, Saint Louis, Missouri, United States
Dartmouth Hitchcock, Lebanon, New Hampshire, United States
Carolina BioOncology, Huntersville, North Carolina, United States
Pennsylvania Cancer Specialists and Research Institute, Gettysburg, Pennsylvania, United States
Prisma Health, Greenville, South Carolina, United States
Sanford Cancer Center, Sioux Falls, South Dakota, United States
Tennessee Oncology, PLLC, Nashville, Tennessee, United States
Mary Crowley Cancer Research, Dallas, Texas, United States
Oncology Consultants, Houston, Texas, United States
South Texas Accelerated Research Therapeutics, LLC, San Antonio, Texas, United States
Contact Details
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