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A Study of Brontictuzumab With Chemotherapy for Subjects With Previously Treated 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: NCT03031691
Recruitment Status : Completed
First Posted : January 25, 2017
Last Update Posted : August 11, 2020
Sponsor:
Information provided by (Responsible Party):
Mereo BioPharma ( OncoMed Pharmaceuticals, Inc. )

Study Description
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Brief Summary:
A Phase 1b Dose Escalation Study of the Safety and Pharmacodynamics of Brontictuzumab in Combination with Chemotherapy for Subjects with Previously Treated Metastatic Colorectal Cancer.

Condition or disease Intervention/treatment Phase
Metastatic Colorectal Cancer Drug: brontictuzumab Drug: trifluridine/tipiracil Phase 1

Detailed Description:

This is a phase 1b dose escalation study of the safety and pharmacodynamics of brontictuzumab in combination with chemotherapy for subjects with previously treated 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 24 months. Patients will be enrolled in two stages: a dose-escalation stage and an expansion phase.

Approximately 34 patients will be enrolled in this study at approximately 5 study centers in the United States.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1b Dose Escalation Study of the Safety and Pharmacodynamics of Brontictuzumab in Combination With Chemotherapy for Subjects With Previously Treated Metastatic Colorectal Cancer
Study Start Date : January 2017
Actual Primary Completion Date : May 2017
Actual Study Completion Date : September 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Brontictuzumab and trifluridine/tipiracil
Brontictuzumab will be administered per protocol and trifluridine/tipiracil per label.
 Drug: brontictuzumab
starting dose of 1.5mg/kg administered intravenously (IV)
Other Name: OMP-52M51

Drug: trifluridine/tipiracil


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of patients with adverse events [ Time Frame: up to approximately 2 years ]
  2. Percentage of patients with dose limiting toxicities [ Time Frame: 28 days ]
  3. Percentage of patients with anti-brontictuzumab antibodies [ Time Frame: up to approximately 2 years ]

Secondary Outcome Measures :
  1. Objective Response according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) [ Time Frame: approximately 2 years ]
  2. Progression-free survival according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1 [ Time Frame: approximately 2 years ]
  3. Changes in number of circulating tumor cells [ Time Frame: approximately 2 years ]
  4. Overall survival [ Time Frame: approximately 2 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed metastatic colorectal cancer (mCRC) previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if KRAS wild-type, an anti-EGFR therapy
  • ECOG performance status 0 or 1

Exclusion Criteria:

  • Prior treatment with gamma secretase inhibitors or other Notch 1 inhibitors
  • Subjects with known active HIV infection. Subjects with HIV that are under a stable anti-retroviral regimen and have no evidence of immune deficiency (normal CD4 counts), undetectable viral load, and no HIV-related infections are eligible
  • Subjects with uncontrolled diarrhea <30 days prior to first administration of study drug

  • Subjects with any history of or current clinically significant gastrointestinal disease including, but not limited to:

    • Inflammatory bowel disease (including ulcerative colitis and Crohn's disease)
    • Active peptic ulcer disease
    • Known intraluminal metastatic lesion(s) with risk of bleeding
Contacts and Locations
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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): NCT03031691


Locations
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United States, Colorado
Denver
Denver, Colorado, United States
United States, Florida
Miami
Miami, Florida, United States
Sarasota
Sarasota, Florida, United States
United States, South Carolina
Charleston
Charleston, South Carolina, United States
United States, Tennessee
Nashville
Nashville, Tennessee, United States
Sponsors and Collaborators
OncoMed Pharmaceuticals, Inc.
More Information
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Responsible Party: OncoMed Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT03031691    
Other Study ID Numbers: 52M51-003
First Posted: January 25, 2017    Key Record Dates
Last Update Posted: August 11, 2020
Last Verified: August 2020
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
Trifluridine
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents