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A Phase 1, First-in-Human, Open Label, Dose Escalation Study of MGD007, A Humanized gpA33 x CD3 Dual-Affinity Re-Targeting (DART) Protein in Patients with Relapsed/Refractory Metastatic Colorectal Carcinoma
The primary goal of this Phase 1 study is to characterize the safety and tolerability of MGD007 and establish the maximum tolerated dose (MTD) of MGD007 administered on either weekly or every three week schedules of administration among patients with metastatic colorectal carcinoma. Pharmacokinetics, pharmacodynamics, and the anti-tumor activity of MGD007 will also be assessed.
Primary Objective(s): To characterize the safety, tolerability, dose-limiting toxicities (DLT) and maximum tolerated dose (MTD) of MGD007 when administered intravenously (IV) on weekly and every three week schedules in patients with relapsed/refractory metastatic colorectal carcinoma.