MGD007 Combined With MGA012 in Relapsed/Refractory Metastatic Colorectal Cancer
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|ClinicalTrials.gov Identifier: NCT03531632|
Recruitment Status : Active, not recruiting
First Posted : May 22, 2018
Last Update Posted : November 5, 2019
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer Metastatic||Biological: MGD007 + MGA012||Phase 1 Phase 2|
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)|
|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|
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
- Number of participants with adverse events [ Time Frame: Up to 30 days after last dose ]Adverse Events, Serious Adverse Events
- Peak plasma concentration [ Time Frame: 7 weeks ]PK of MGD007 and MGA012 in combination
- Number of participants that develop anti-drug antibodies [ Time Frame: 1 year ]Proportion of patients who develop anti-MGD007/MGA012 antibodies, immunogenicity
- 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.
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
|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|
|Study Director:||Jan Davidson-Moncada, MD PhD||MacroGenics|