NCT03035253

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

A Phase 1b Study of OMP-305B83 Plus FOLFIRI or FOLFOX as Second Line Therapy in Subjects With Metastatic Colorectal Cancer

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: OncoMed Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Metastatic Colorectal Cancer

Interventions

Type	Name	Description
DRUG	OMP-305B83
DRUG	FOLFIRI	Treatment will consist of OMP-305B83 and the FOLFIRI chemotherapy regimen.
DRUG	FOLFOX	Treatment will consist of OMP-305B83 and the FOLFOX chemotherapy regimen.

Timeline

• Start date: 2016-12-01
• Primary completion: 2018-09-01
• Completion: 2018-12-01
• First posted: 2017-01-27
• Last updated: 2020-08-11

Locations

6 sites across 1 country: United States