This is a Phase 1 open-label, dose-escalation trial using "3+3" design, evaluating MM-151 co-administration with MM-121, MM-141, and trametinib at varying dose levels.
This is a two-part Phase 1, non-randomized, open-label study of MM-151 plus MM-121, MM-141, or trametinib in patients with advanced, heregulin-positive lung, head and neck, and colorectal cancers. In part 1 of the study, cohorts of 3 or more patients will be treated at escalating doses of MM-151 in combination with MM-121, MM-141, and trametinib until a maximum tolerated combination dose for each combination is identified. In part 2 of the study, patients will be treated with the combination dose identified in part 1 of the study.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
5
University of Colorado
Aurora, Colorado, United States
Northside Hospital
Sandy Springs, Georgia, United States
Northwestern
Chicago, Illinois, United States
Washington University
St Louis, Missouri, United States
To find a phase II dose of MM-151 in combination with MM-121, MM-141, and trametinib based on maximum tolerated dose (MTD) in patients with lung, head and neck, and colorectal cancers
Time frame: 1.5 years
Number of dose limiting toxicities (DLTs) within a group
Time frame: 1.5 years
Adverse event profile of MM-151 in combination with MM-121, MM-141, and trametinib
Time frame: 1.5 years
Objective response to MM-151 in combination with MM-121, MM-141, and trametinib based on RECIST
Time frame: 1.5 years
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trametininb
Vanderbilt
Nashville, Tennessee, United States