Clinical Trial - NCT03531632

MGD007 Combined With MGA012 in Relapsed/Refractory Metastatic Colorectal Cancer

Recruiting

Sponsor: MacroGenics

Collaborators:

Information provided by (Responsible party): Sponsor

ClinicalTrials.gov Identifier: NCT03531632

Protocol Info

Short Description: MGD007 + MGA012 In Colorectal Carcinoma
Long Description: 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
MGH Status: Open
Sponsor: MacroGenics, Inc.
Disease Program: GI

Next Steps


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Purpose

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 Title Intervention Phase
Colorectal Cancer Metastatic MGD007 + MGA012 Phase 1/Phase 2
Study Type Interventional
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

Primary Outcome Measures

Number of participants with adverse events [Time Frame: Up to 30 days after last dose] [Designated as safety issue: ]


Secondary Outcome Measures

Peak plasma concentration [Time Frame: 7 weeks] [Designated as safety issue: ]

Number of participants that develop anti-drug antibodies [Time Frame: 1 year] [Designated as safety issue: ]

Change in tumor volume [Time Frame: Every 8 weeks] [Designated as safety issue: ]

Estimated Enrollment: 52
Study Start Date: June 2018
Estimated Study Completion Date: April 2022
Estimated Primary Completion Date: April 2020
Arms Assigned Interventions

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.

Eligibility

Ages Eligible for Study: N/A-N/A

Genders Eligible for Study: All

Accepts Healthly Volunteers: No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT03531632

Locations

  • United States, Connecticut
    • Yale School of Medicine New Haven, Connecticut, United States, 06520
  • United States, Florida
    • Moffitt Cancer Center Tampa, Florida, United States, 33612
  • United States, Massachusetts
    • Massachusetts General Hospital Boston, Massachusetts, United States, 02114
  • United States, New York
    • University of Rochester Medical Center Rochester, New York, United States, 14642
  • United States, North Carolina
    • Carolina Biooncology Institute Huntersville, North Carolina, United States, 28078
  • United States, Washington
    • University of Washington Seattle, Washington, United States, 98109

Sponsors and Collaborators

MacroGenics

More Information

No publications provided

Responsible Party: Sponsor
ClinicalTrials.gov Identifier: NCT03531632
Other Study ID Numbers:
Study First Received:
Last Updated:
Health Authority:

Additional relevant MeSH terms:

Colorectal Neoplasms

Next Steps


If you are interested in this protocol or in other treatment options at Massachusetts General Hospital, please Request a Consultation.







ClinicalTrials.gov processed this data on August 15, 2019