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

NCT03035253 | Terminated Phase 1

• 1 other identifier: B83-003
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 6

Brief 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.

Conditions

Metastatic Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

• 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

• Response Rate assessed by RECIST criteria 1.1

  At 56 day intervals while on treatment, through study completion, an average of 8 months

• Response Rate assessed by tumor marker CEA

  At 28 day intervals while on treatment, through study completion, an average of 8 months

• Progression Free Survival

  Up to 5 years

Study Arms (1)

OMP-305B83 combined with FOLFIRI or FOLFOX

EXPERIMENTAL

Drug: OMP-305B83; Drug: FOLFIRI; Drug: FOLFOX

Interventions

OMP-305B83 DRUG

Also known as: bispecific monoclonal antibody

OMP-305B83 combined with FOLFIRI or FOLFOX

FOLFIRI DRUG

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

OMP-305B83 combined with FOLFIRI or FOLFOX

FOLFOX DRUG

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

OMP-305B83 combined with FOLFIRI or FOLFOX

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• OncoMed Pharmaceuticals, Inc.: lead

Study Sites (6)

City of Hope National Medical Center

Duarte, California, 91010, United States

Location

Rocky Mountain Cancer Centers

Denver, Colorado, 80218, United States

Location

Cancer Care & Hematology - Fort Collins

Fort Collins, Colorado, 80528, United States

Location

University of Michigan Health System

Ann Arbor, Michigan, 48109-2800, United States

Location

Washington University School of Medicine Siteman Cancer Center

St Louis, Missouri, 63110, United States

Location

University of Utah, Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

navicixizumab; Antibodies, Bispecific; IFL protocol; Folfox protocol

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2016
• First Posted: January 27, 2017
• Study Start: December 1, 2016
• Primary Completion: September 1, 2018
• Study Completion: December 1, 2018
• Last Updated: August 11, 2020

Record last verified: 2020-08

Locations

US (6)