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A Phase 1b Study of OMP-305B83 Plus FOLFIRI or FOLFOX as Second Line Therapy in Subjects With Metastatic Colorectal Cancer
The purpose of this study is to test the safety and efficacy of an experimental drug, OMP-305B83, when given in combination with FOLFIRI or FOLFOX. OMP-305B83 is a humanized bispecific monoclonal antibody and was developed to target cancer stem cells. Based on preclinical studies, it is believed that OMP-305B83 may block the growth of cancer stem cells and may also impair the productive growth of new blood vessels, which tumors need to grow and spread. The study is sponsored by OncoMed Pharmaceuticals, which is referred to as OncoMed or the Sponsor.
This is an open-label, Phase 1b dose escalation and expansion study of OMP-305B83 plus FOLFIRI or FOLFOX to evaluate the safety, efficacy, and pharmacokinetics of OMP-305B83 in combination with FOLFIRI or FOLFOX in patients with metastatic Colorectal Cancer. This study consists of a screening period, a treatment period, and a post-treatment follow-up period in which patients will be followed for survival for up to 5 years. Patients will be enrolled in two stages: a dose-escalation stage and an expansion phase.
Age
21 - No limit years
Sex
ALL
Healthy Volunteers
No
City of Hope National Medical Center
Duarte, California, United States
Rocky Mountain Cancer Centers
Denver, Colorado, United States
Cancer Care & Hematology - Fort Collins
Fort Collins, Colorado, United States
University of Michigan Health System
Ann Arbor, Michigan, United States
Washington University School of Medicine Siteman Cancer Center
St Louis, Missouri, United States
University of Utah, Huntsman Cancer Institute
Salt Lake City, Utah, United States
Start Date
December 1, 2016
Primary Completion Date
September 1, 2018
Completion Date
December 1, 2018
Last Updated
August 11, 2020
16
ACTUAL participants
OMP-305B83
DRUG
FOLFIRI
DRUG
FOLFOX
DRUG
Lead Sponsor
OncoMed Pharmaceuticals, Inc.
NCT06625775
NCT04657068
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.
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