Protocol #: 18-424
Status
Recruiting
Description
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
Colorectal Cancer Metastatic
Interventions
MGD007 + MGA012
Phase
Phase 1/Phase 2
Study Type
Interventional
Further Study Details
Primary Outcome:
Number of participants with adverse events
Secondary Outcome:
Peak plasma concentration
Number of participants that develop anti-drug antibodies
Change in tumor volume
Estimated Enrollment
52
Study Start Date
June 4, 2018
Eligibility
Gender: All
Minimum Age: 18 Years
Maximum Age: N/A
Health Volunteers: No
Criteria
MacroGenics
Information Provided By
MacroGenics
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
Clinicaltrials.gov Identifier
NCT03531632

 

 

Source: Clinicaltrials.gov. Through our founding membership in the Dana-Farber/Harvard Cancer Center, an NCI-designated Comprehensive Cancer Center, these clinical trials are conducted at the Massachusetts General Hospital Cancer Center and may be available at other partner institutions.

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