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

OncoMed Pharmaceuticals

Status and phase

Terminated

Phase 1

Conditions

Metastatic Colorectal Cancer

Treatments

Drug: OMP-305B83

Drug: FOLFOX

Drug: FOLFIRI

Study type

Interventional

Funder types

Industry

Identifiers

NCT03035253

B83-003

Details and patient eligibility

About

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.

Full 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.

Enrollment

16 patients

Sex

All

Ages

21+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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