NCT03531632

MGD007 Combined With MGA012 in Relapsed/Refractory Metastatic Colorectal Cancer

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: MacroGenics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Colorectal Cancer Metastatic

Interventions

Type	Name	Description
BIOLOGICAL	MGD007 + MGA012	MGD007 and MGA012 are administered by IV infusion.

Timeline

• Start date: 2018-06-04
• Primary completion: 2020-02-08
• Completion: 2020-02-08
• First posted: 2018-05-22
• Last updated: 2022-02-08
• Results posted: 2021-11-10

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated drug study