RWF_CP-MGD007-01

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.

Inclusion Criteria:

• For the dose escalation cohorts, histologically-proven metastatic colorectal adenocarcinoma that is refractory to 2 prior standard treatment regimens or standard treatment was declined.

• For the dose expansion cohorts, histologically-proven metastatic colorectal adenocarcinoma that is refractory to 1 prior standard treatment regimen or standard therapy was declined.

• Life expectancy of at least 12 weeks

• Measurable disease

• Intolerance to at least 2 prior standard therapy regimens

• Acceptable laboratory parameters

Exclusion Criteria:

• Any prior history of or suspected current autoimmune disorders (with the exception of vitiligo, resolved childhood atopic dermatitis, prior Grave's disease)

• Prior history of allogeneic bone marrow, stem-cell, or solid organ transplantation
Phase I
NCT02248805
Oncology
Gastrointestinal
Todd Crocenzi, M.D.
MacroGenics, Inc
Yue-Yun To
  • Oncology and Hematology Care Eastside