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

Metastatic Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03035253
• Other study ID #: B83-003
• Status: Terminated
• Phase: Phase 1
• Start date: December 2016
• Est. completion date: December 2018

Study information

• Verified date: August 2020
• Source: Mereo BioPharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 16
• Est. completion date: December 2018
• Est. primary completion date: September 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Metastatic Colorectal Cancer

Intervention

Drug:
• OMP-305B83

• FOLFIRI
Treatment will consist of OMP-305B83 and the FOLFIRI chemotherapy regimen.
• FOLFOX
Treatment will consist of OMP-305B83 and the FOLFOX chemotherapy regimen.

Locations

Country	Name	City	State
United States	University of Michigan Health System	Ann Arbor	Michigan
United States	Rocky Mountain Cancer Centers	Denver	Colorado
United States	City of Hope National Medical Center	Duarte	California
United States	Cancer Care & Hematology - Fort Collins	Fort Collins	Colorado
United States	Washington University School of Medicine Siteman Cancer Center	Saint Louis	Missouri
United States	University of Utah, Huntsman Cancer Institute	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
OncoMed Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of dose limiting toxicities	The maximum tolerated dose (MTD) or maximum administered dose (MAD) will be determined in patients treated with OMP-305B83 in combination with FOLFIRI or FOLFOX	Subjects will be treated and observed for DLT through the end of the first cycle (Days 0-28).
Secondary	Safety of OMP-305B83 in combination with FOLFIRI or FOLFOX will be assessed by adverse event monitoring, physical exams, vital signs, clinical laboratory testing, ECGs, echocardiograms, anti-OMP-305B83 testing, and subject interview on an ongoing basis.		Through study completion, an average of 8 months
Secondary	Immunogenicity (in terms of formation of anti-drug antibod(ies) against OMP-305B83 in percentage of subjects) of OMP-305B83 in combination with FOLFIRI or FOLFOX		Through study completion, an average of 8 months
Secondary	Response Rate assessed by RECIST criteria 1.1		At 56 day intervals while on treatment, through study completion, an average of 8 months
Secondary	Response Rate assessed by tumor marker CEA		At 28 day intervals while on treatment, through study completion, an average of 8 months
Secondary	Progression Free Survival		Up to 5 years