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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03035253
Recruitment Status : Terminated
First Posted : January 27, 2017
Last Update Posted : March 13, 2019
Sponsor:
Information provided by (Responsible Party):
OncoMed Pharmaceuticals, Inc.

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.


Condition or disease Intervention/treatment Phase
Metastatic Colorectal Cancer Drug: OMP-305B83 Drug: FOLFIRI Drug: FOLFOX Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1b Study of OMP-305B83 Plus FOLFIRI or FOLFOX as Second Line Therapy in Subjects With Metastatic Colorectal Cancer
Study Start Date : December 2016
Actual Primary Completion Date : September 2018
Actual Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: OMP-305B83 combined with FOLFIRI or FOLFOX Drug: OMP-305B83
Other Name: 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.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. Response Rate assessed by tumor marker CEA [ Time Frame: At 28 day intervals while on treatment, through study completion, an average of 8 months ]
  5. Progression Free Survival [ Time Frame: Up to 5 years ]


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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03035253


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

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Responsible Party: OncoMed Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT03035253     History of Changes
Other Study ID Numbers: B83-003
First Posted: January 27, 2017    Key Record Dates
Last Update Posted: March 13, 2019
Last Verified: March 2019

Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Antibodies, Bispecific
Immunologic Factors
Physiological Effects of Drugs