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A Phase 1, 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 Acute Myeloid Leukemia

Status
Active
Cancer Type
Leukemia
Trial Phase
Phase I
Eligibility
18 and over, Male and Female
Study Type
Biomarker/Laboratory analysis
Treatment
NCD ID
NCT02152956
Protocol IDs
CP-MGD006-01 (primary)
NCI-2014-01526
Study Sponsor
MacroGenics Inc

Summary

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

MGD006.

Objectives

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.

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