The primary goal of this Phase 1/2, dose-escalation study, is to determine the maximum tolerated dose level of flotetuzumab 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 [PK], pharmacodynamics) and to evaluate potential anti-tumor activity of flotetuzumab.
A Phase 1/2, First in Human, Dose Escalation Study of MGD006, a CD123 x CD3 Dual Affinity Re-Targeting (DART®) Bi-Specific Antibody Based Molecule, in Patients With Relapsed or Refractory AML or Intermediate-2/High Risk MDS
Open-label, multi-dose, single-arm, multi-center, Phase 1/2, dose-escalation study to define a maximum tolerated dose and schedule (MTDS), describe preliminarily safety, and to assess PK, immunogenicity, immunomodulatory activity, and potential anti-tumor activity of flotetuzumab 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.
The Multi-Patient Dose Escalation Segment will employ a classical 3+3 scheme to examine a series of increasing dose escalations in cohorts of patients with AML.
Any Dose Escalation Cohort not exceeding the maximum tolerated dose may be expanded to include up to 15 patients for further evaluation of the safety, PK, and preliminary anti-tumor activity of flotetuzumab. Once the MTDS is established, the cohort of patients treated at that dose/schedule or a lower dose, will be expanded with the addition of up to 120 AML patients.