The primary goal of this Phase 1, dose-escalation study, is to determine the maximum
tolerated dose level of MGD006 in patients with AML whose disease is not expected to benefit
from cytotoxic chemotherapy. Studies will also be done to see how the drug acts in the body
(pharmacokinetics, pharmacodynamics) and to evaluate potential anti-tumor activity of
Open-label, multi-dose, single-arm, multi-center, Phase 1, dose-escalation study to define a
MTDS, describe preliminarily safety, and to assess PK, immunogenicity, immunomodulatory
activity, and potential anti-tumor activity of MGD006 in patients with AML whose disease is
not expected to benefit from cytotoxic chemotherapy.
This study is designed in three segments: the Single Patient Dose Escalation Segment,
followed by the Multi-Patient Dose Escalation Segment and the MTDS Expansion Cohort Segment.
Transition to the Multi-Patient Dose Escalation Segment of the study will be based on review
of the aggregate safety data on all patients participating in Cohort 0.
The Multi-Patient Dose Escalation Segment will employ a classical 3+3 scheme to examine a
series of increasing one-step dose escalations in sequential cohorts of patients.
Once the MTDS is established, the cohort of patients treated at that dose/schedule will be
expanded with the addition of 12 patients to increase the safety experience and more fully
evaluate the PK and pharmacodynamics of MGD006.
In all segments of the study, patients who benefit from MGD006 treatment, and continue to
meet eligibility, may continue treatment in Cycles 2 and beyond.