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.
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
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
38
MGD007 and MGA012 are administered by IV infusion.
Yale School of Medicine
New Haven, Connecticut, United States
Moffitt Cancer Center
Tampa, Florida, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
University of Rochester Medical Center
Rochester, New York, United States
Number of Participants With Adverse Events
Adverse Events, Serious Adverse Events
Time frame: Up to approximately 12 weeks
Peak Plasma Concentration
PK of MGD007 and MGA012 in combination
Time frame: 7 weeks
Number of Participants That Develop Anti-drug Antibodies
Proportion of patients who develop anti-MGD007/MGA012 antibodies, immunogenicity
Time frame: 1 year
The Number of Participants With Response Based on the Change in Tumor Volume
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) and immune related RECIST criteria: number of patients with either complete response (CR) or partial response (PR) will determine the Overall Response Rate (ORR)
Time frame: Every 8 weeks
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Carolina Biooncology Institute
Huntersville, North Carolina, United States
University of Washington
Seattle, Washington, United States