This is an open-label Phase 1a/b dose-escalation study to assess the safety, tolerability, and PK of OMP-131R10 as a single agent for advanced solid tumors and in subjects with metastatic colorectal cancer.
The Phase 1a portion of the study in subjects with advanced solid tumors will consist of a dose escalation part followed by a dose-expansion cohort. OMP-131R10 will be administered IV on the first day of each 14-day cycle. Dose escalation will follow a traditional 3+3 framework. Treatment will be continued until progressive disease or unacceptable toxicity. The Phase 1b portion of the study will be conducted in subjects with metastatic colorectal cancer whose tumors have progressed after at least 1 line of therapy for metastatic disease. Treatment will consist of OMP-131R10 and the FOLFIRI chemotherapy regimen.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
There are 5 planned dose cohorts of OMP-131R10. Dose escalation will follow a traditional 3+3 framework. Treatment will be continued until progressive disease or unacceptable toxicity.
Treatment will consist of OMP-131R10 and the FOLFIRI chemotherapy regimen.
UCSF
San Francisco, California, United States
University of Colorado Hospital Anschulz Cancer Pavilion
Aurora, Colorado, United States
Yale
New Haven, Connecticut, United States
Massachusetts General Hospital, Dana Farber Cancer Institute
Boston, Massachusetts, United States
Incidence of dose limiting toxicities (DLTs)
Subject will be assessed for DLTs during the evaluation window (28 days). Once the maximum tolerated dose (MTD) or maximum administered dose (MAD) has been determined.
Time frame: DLTs during the evaluation (28 days)
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Duke University
Durham, North Carolina, United States
The Sarah Cannon Research Institute
Nashville, Tennessee, United States
M.D. Anderson Cancer Center
Houston, Texas, United States