In:
Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 35, No. 15_suppl ( 2017-05-20), p. TPS7070-TPS7070
Abstract:
TPS7070 Background: MGD006/S80880 is a novel CD123 x CD3 DART molecule designed to target CD123-positive cells for recognition and elimination by CD3-expressing T lymphocytes as effector cells. CD123, the alpha chain of the interleukin 3 receptor (IL-3Ra) is known to be highly expressed in 〉 90% of AML patients and at least 50% of MDS patients. Based on these observations, targeting CD123 could be a promising strategy in the preferential ablation of AML and MDS cells. Methods: MGD006 is currently being evaluated in a Phase 1 dose-escalation and cohort expansion study in relapsed/refractory (R/R) AML or intermediate-2/high risk MDS. The objectives of the study are to determine the MTDS and safety profile, and describe the pharmacokinetics and preliminary activity of MGD006. Patients are dosed in 28-day cycles. All patients start with a lead-in continuous IV infusion of 30ng/kg/day for 3 days followed by 100ng/kg/day for 4 days. Subsequent weeks (2-4) are dosed in two different schedules. One arm receives MGD006 for 4 days on/3 days off and the second arm receives MGD006 for 7 days continuously at the maximal dose assigned to each cohort (up to 1000ng/kg/day). Beginning with the second cycle, all patients are administered MGD006 for 4 days on/3 days off at the maximal dose/cohort. Patients can continue on treatment until 2 cycles (8 weeks) after the attainment of a CR, maximum of 12 cycles of MGD006, DLT or treatment failure. Once the MTDS is identified, two cohorts of 24 patients each, one in AML and one in MDS, will be enrolled. Response is assessed by IWG or IPSS criteria for AML and MDS, respectively. Signs and symptoms of cytokine release syndrome (CRS), a common AE, are graded according to Lee criteria. The study continues to enroll patients with open sites in the US, France, Germany, Italy, and The Netherlands. ClinicalTrials.gov #NCT02152956. EudraCT #2015-003813-11.
Type of Medium:
Online Resource
ISSN:
0732-183X
,
1527-7755
DOI:
10.1200/JCO.2017.35.15_suppl.TPS7070
Language:
English
Publisher:
American Society of Clinical Oncology (ASCO)
Publication Date:
2017
detail.hit.zdb_id:
2005181-5
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