A Study of OMP-305B83 in Subjects With Metastatic Colorectal Cancer

Stopped early · Phase 1

Conditions studied: Metastatic Colorectal Cancer

In brief

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.

Key facts

Study ID

NCT03035253

Run by

OncoMed Pharmaceuticals, Inc.

People needed

16

Starts

2016-12-01

Expected to finish

2018-12-01

Last updated by the study team

2020-08-11

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Measurable disease per response evaluation criteria in solid tumors (RECIST) v1.1
• Age >21 years
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Adequate organ and marrow function
• For women of childbearing potential and men with partners of childbearing potential, agreement (by patient and/or partner) to use two effective forms of contraception from study entry through at least 6 months after the termination visit.
• Ability to understand and the willingness to sign a written informed consent document

You may not qualify if…

• Receiving any other investigational agents or any other anti-cancer therapy
• Receiving prior hepatic intra-arterial chemotherapy
• Known significant clinically significant gastrointestinal disease
• Patients with brain metastases (treated or untreated) leptomeningeal disease, uncontrolled seizure disorder, or active neurologic disease
• Significant intercurrent illness that will limit the patient's ability to participate in the study or may result in their death over the next 18 months
• Pregnant or nursing women
• Inability to comply with study and follow up procedure

Where it is running

• 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

Full record on ClinicalTrials.gov

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