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MGD007 Combined With MGA012 in Relapsed/Refractory Metastatic Colorectal Cancer

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ClinicalTrials.gov Identifier: NCT03531632
Recruitment Status : Recruiting
First Posted : May 22, 2018
Last Update Posted : November 19, 2018
Sponsor:
Information provided by (Responsible Party):
MacroGenics

Brief Summary:
The primary goal of this study is to characterize the safety, tolerability, and maximum tolerated dose (MTD) of MGD007 when combined with MGA012. Pharmacokinetics (PK), immunogenicity, pharmacodynamics (PD), and the anti-tumor activity of the combination of MGD007 and MGA012 will also be assessed.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Metastatic Biological: MGD007 + MGA012 Phase 1 Phase 2

Detailed Description:

This study is an open-label, Phase 1b/2, dose escalation and cohort expansion study designed to characterize the safety, tolerability, PK, PD, immunogenicity, and preliminary antitumor activity of MGD007 and MGA012, administered in combination by IV infusion, in patients with histologically proven, relapsed/refractory metastatic colorectal carcinoma, irrespective of the KRAS and MMR status of their tumors.

The study consists of a Dose Escalation Phase to determine the MTD or Maximum Administered Dose (MAD; if no MTD is defined) of the combination, followed by a Cohort Expansion Phase to further define the safety and initial antitumor activity of the combination with the doses established in the Dose Escalation Phase.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 52 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1b/2, Open Label, Dose Escalation Study of MGD007, a Humanized gpA33 × CD3 DART® Protein in Combination With MGA012, an Anti-PD-1 Antibody, in Patients With Relapsed or Refractory Metastatic Colorectal Carcinoma
Actual Study Start Date : June 4, 2018
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : April 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: MGD007 + MGA012
MGD007 is a gpA33 x CD3 bi-specific DART antibody; MGA012 is an anti-PD-1 monoclonal antibody.
Biological: MGD007 + MGA012
MGD007 and MGA012 are administered by IV infusion.
Other Name: MGA012 also known as INCMGA00012




Primary Outcome Measures :
  1. Number of participants with adverse events [ Time Frame: Up to 30 days after last dose ]
    Adverse Events, Serious Adverse Events


Secondary Outcome Measures :
  1. Peak plasma concentration [ Time Frame: 7 weeks ]
    PK of MGD007 and MGA012 in combination

  2. Number of participants that develop anti-drug antibodies [ Time Frame: 1 year ]
    Proportion of patients who develop anti-MGD007/MGA012 antibodies, immunogenicity

  3. Change in tumor volume [ Time Frame: Every 8 weeks ]
    Anti-tumor activity of MGD007+MGA012 using both conventional RECIST 1.1 and immune-related RECIST 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 proven, relapsed/refractory metastatic colorectal cancer
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • Measurable disease per RECIST 1.1 criteria
  • Participants in the Dose Escalation Phase must have had recurrence, progression or intolerance to standard therapy consisting of at least 2 prior standard regimens (containing a fluoropyrimidine plus a platinum analogue and/or irinotecan) for metastatic disease. Participants in the Cohort Expansion portion will be allowed to participate after 1 prior standard regimen. Those who are inappropriate candidates for or have refused treatment with these regimens are also eligible. No more than 5 prior therapies are permitted. Patients previously treated with MGD007 on Study Protocol CP-MGD007-01 and who did not develop antibodies to MGD007 while on the CP-MGD007-01 study, may be enrolled. Patients that were previously treated on CP-MGD007-01 will only be treated on this study once MTD/MAD has been defined.
  • Availability of sufficient tumor specimens to enable retrospective determination of gpA33, CD3, PD-1, and PD-L1 expression
  • 30 participants in the Cohort Expansion portion must have lesions that are accessible for paired biopsies with acceptable clinical risk in the judgment of the investigator.

Exclusion Criteria:

  • Symptomatic central nervous system (CNS) metastases. No concurrent treatment for the CNS disease; no progression of CNS metastases on MRI or CT for at least 14 days after last day of prior therapy for the CNS metastases; no concurrent leptomeningeal disease or cord compression
  • History of known or suspected autoimmune disease with certain exceptions
  • History of prior allogeneic bone marrow, stem-cell, or solid organ transplantation.
  • Major surgery, systemic anti-neoplastic therapy, or investigational therapy within 4 weeks
  • Radiation therapy within 2 weeks
  • Systemic corticosteroids (≥ 10 mg per day prednisone or equivalent) or other immune suppressive drugs within the 14 days
  • History of Grade 3 or greater drug-related diarrhea/colitis during treatment with checkpoint inhibitors including anti-LAG-3, anti-PD-1, anti PD-L1, or anti-CTLA-4 antibodies
  • Clinically significant cardiovascular disease; gastrointestinal disorders; pulmonary compromise; viral, bacterial, or systemic fungal infections
  • History of positive testing for human immunodeficiency virus or history of acquired immune deficiency syndrome
  • History of hepatitis B or hepatitis C infection or known positive test for hepatitis B surface antigen, hepatitis B core antigen, or hepatitis C polymerase chain reaction.

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): NCT03531632


Contacts
Contact: Susan Brann (240) 552-8023 branns@macrogenics.com
Contact: Joanna Lohr (240) 552-8030 lohrj@macrogenics.com

Locations
United States, North Carolina
Carolina Biooncology Institute Recruiting
Huntersville, North Carolina, United States, 28078
Contact: Jaelyn Linski    704-947-6599 ext 111    jlinski@carolinabiooncology.org   
Principal Investigator: John Powderly, MD         
Sponsors and Collaborators
MacroGenics
Investigators
Study Director: Jan Davidson-Moncada, MD PhD MacroGenics

Responsible Party: MacroGenics
ClinicalTrials.gov Identifier: NCT03531632     History of Changes
Other Study ID Numbers: CP-MGD007-02
First Posted: May 22, 2018    Key Record Dates
Last Update Posted: November 19, 2018
Last Verified: November 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases