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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
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
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
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
St 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
Start Date
May 27, 2021
Primary Completion Date
October 31, 2024
Completion Date
October 31, 2024
Last Updated
November 4, 2024
64
ACTUAL participants
MT-6402
DRUG
Lead Sponsor
Molecular Templates, Inc.
NCT05720117
NCT06898450
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07190248