Safety Study of MGD006 in Relapsed/Refractory Acute Myeloid Leukemia (AML) or Intermediate-2/High Risk MDS
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|ClinicalTrials.gov Identifier: NCT02152956|
Recruitment Status : Recruiting
First Posted : June 2, 2014
Last Update Posted : November 1, 2019
|Condition or disease||Intervention/treatment||Phase|
|AML||Drug: Flotetuzumab||Phase 1 Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||179 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Study Start Date :||May 2014|
|Estimated Primary Completion Date :||January 2020|
|Estimated Study Completion Date :||April 2020|
CD123 x CD3 bispecific DART® antibody
Flotetuzumab is a CD123 x CD3 bispecific antibody-based molecular construct referred to as a DART® molecule.
Other Name: MGD006, S80880
- Occurrence of dose limiting toxicity [ Time Frame: Cycle 1 of a 28 day cycle. ]• Maximum Tolerated Dose/Schedule: the MTDS will be defined as the highest dose/schedule administered during any Cohort in the study at which the incidence of DLT is < 33% during the first cycle of MGD006 treatment.
- Occurrence of adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: Up to 7 months ]
- Occurrence of anti-leukemic activity [ Time Frame: Every 28 days ]
- Measure the pharmacokinetics (PK) of flotetuzumab [ Time Frame: Cycle 1 through end of treatment (28 day cycles) ]
- Occurrence of anti-drug antibody [ Time Frame: Cycle 1 through end of treatment (28 day cycles) ]ADA
- Overall survival [ Time Frame: Time from first dose to death from any cause; assessed up to 2 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02152956
|Contact: Kathy Tran||trank@Macrogenics.com|
|Principal Investigator:||John DiPersio, MD, PhD||Washington University School of Medicine|
|Study Director:||Jan Davidson-Moncada, MD, PhD||MacroGenics|
|Principal Investigator:||Norbert Vey, MD||Institute Paoli-Calmettes|