This study is a Phase 1 and pharmacologic open-labeled dose-escalation trial using a "3+3" design, evaluating MM-151 at varying dose levels and frequencies, and subsequently in combination with irinotecan.
This study is a Phase 1 and pharmacologic open-labeled dose-escalation trial using a "3+3" design exploring weekly, bi-weekly, and tri-weekly dosing schedules. Successive MM-151 monotherapy cohorts of three or more patients will be treated at escalating doses until a maximum tolerated dose is identified, and subsequently in combination with irinotecan. The study consists of three parts as follows: MM-151 monotherapy dose escalation (Part 1); MM-151 monotherapy expansion cohort in cetuximab-refractory colorectal cancer (Part 2); MM-151 + irinotecan dose escalation (Part 3). It is expected that approximately 4 study sites will participate.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
112
MM-151
MM-151 + irinotecan
University of Colorado Denver
Aurora, Colorado, United States
Horizon Oncology Research, Inc.
Lafayette, Indiana, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
South Texas Accelerated Research Therapeutics, LLC (START)
San Antonio, Texas, United States
Phase II dose of MM-151 alone and in combination with irinotecan based either on the maximum tolerated dose (MTD) or maximum dose of 18 mg/kg in patients with advanced solid malignancies.
Time frame: Two years
Number of dose limiting toxicities (DLTs) within a cohort
Time frame: 2 years
Adverse event profile of MM-151 alone and in combination with irinotecan
Time frame: 2 years
Objective response to MM-151 alone and in combination with irinotecan based on RECIST
Time frame: 2 years
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