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

August 10, 2020 updated by: OncoMed Pharmaceuticals, Inc.

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Duarte, California, United States, 91010
        • City of Hope National Medical Center
    • Colorado
      • Denver, Colorado, United States, 80218
        • Rocky Mountain Cancer Centers
      • Fort Collins, Colorado, United States, 80528
        • Cancer Care & Hematology - Fort Collins
    • Michigan
      • Ann Arbor, Michigan, United States, 48109-2800
        • University of Michigan Health System
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine Siteman Cancer Center
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • University of Utah, Huntsman Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: OMP-305B83 combined with FOLFIRI or FOLFOX
Drug: OMP-305B83
Other Names:
  • bispecific monoclonal antibody
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of dose limiting toxicities
Time Frame: Subjects will be treated and observed for DLT through the end of the first cycle (Days 0-28).
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 Outcome Measures

Outcome Measure
Time Frame
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.
Time Frame: Through study completion, an average of 8 months
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
Time Frame: Through study completion, an average of 8 months
Through study completion, an average of 8 months
Response Rate assessed by RECIST criteria 1.1
Time Frame: At 56 day intervals while on treatment, through study completion, an average of 8 months
At 56 day intervals while on treatment, through study completion, an average of 8 months
Response Rate assessed by tumor marker CEA
Time Frame: At 28 day intervals while on treatment, through study completion, an average of 8 months
At 28 day intervals while on treatment, through study completion, an average of 8 months
Progression Free Survival
Time Frame: Up to 5 years
Up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

OncoMed Pharmaceuticals, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2016

Primary Completion (ACTUAL)

September 1, 2018

Study Completion (ACTUAL)

December 1, 2018

Study Registration Dates

First Submitted

December 22, 2016

First Submitted That Met QC Criteria

January 25, 2017

First Posted (ESTIMATE)

January 27, 2017

Study Record Updates

Last Update Posted (ACTUAL)

August 11, 2020

Last Update Submitted That Met QC Criteria

August 10, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B83-003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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