MGD007 Combined With MGA012 in Relapsed/Refractory Metastatic Colorectal Cancer

NCT03531632 | Completed Phase 1 Results FDA Drug

• 1 other identifier: CP-MGD007-02
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 6

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.

Conditions

Colorectal Cancer Metastatic

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Adverse Events

  Adverse Events, Serious Adverse Events

  Up to approximately 12 weeks

Secondary Outcomes (3)

• Peak Plasma Concentration

  7 weeks

• Number of Participants That Develop Anti-drug Antibodies

  1 year

• The Number of Participants With Response Based on the Change in Tumor Volume

  Every 8 weeks

Study Arms (1)

MGD007 + MGA012

EXPERIMENTAL

MGD007 is a gpA33 x CD3 bi-specific DART antibody; MGA012 is an anti-PD-1 monoclonal antibody.

Biological: MGD007 + MGA012

Interventions

MGD007 + MGA012 BIOLOGICAL

MGD007 and MGA012 are administered by IV infusion.

Also known as: MGA012 also known as INCMGA00012

MGD007 + MGA012

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• MacroGenics: lead

Study Sites (6)

Yale School of Medicine

New Haven, Connecticut, 06520, United States

Location

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

Carolina Biooncology Institute

Huntersville, North Carolina, 28078, United States

Location

University of Washington

Seattle, Washington, 98109, United States

Location

Results Point of Contact

• Title: Stephen Eck, M.D., Chief Medical Officer
• Organization: MacroGenics, Inc.

ecks@macrogenics.com

301 251-5172

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2018
• First Posted: May 22, 2018
• Study Start: June 4, 2018
• Primary Completion: February 8, 2020
• Study Completion: February 8, 2020
• Last Updated: February 8, 2022
• Results First Posted: November 10, 2021

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)