Last updated on February 2020

First in Human Testing of Dose-escalation of SAR440234 in Patients With Acute Myeloid Leukemia Acute Lymphoid Leukemia and Myelodysplastic Syndrome

Brief description of study

Primary Objective:

  • Dose escalation: To determine the maximum tolerated dose (MTD) of SAR440234 administered as a single agent in patients with R/R AML (relapsed or refractory acute myeloid leukemia), HR-MDS (high risk myelodysplastic syndrome), or B-ALL (B-cell acute lymphoblastic leukemia), and determine the recommended phase 2 dose (RP2D) for the subsequent Expansion part.
  • Expansion part: To assess the activity of single agent SAR440234 at the RP2D in patients with R/R AML or HR-MDS.

Secondary Objective:

  • To characterize the safety profile including cumulative adverse drug reactions.
  • To evaluate the potential immunogenicity of SAR440234.
  • To assess any preliminary evidence of hematologic response in the Dose Escalation Part.

Detailed Study Description

The duration of the study for the patients will include a period for screening of up to 14 days. The cycle duration is 42 days. Patients will continue study treatment as long as clinical benefit is possible or until disease progression, unacceptable adverse reaction, patient's decision to stop treatment, or other reason of discontinuation. After study treatment discontinuation patients will return to the study site 30 days after the last administration of SAR440234 for end of treatment assessments. Patients without documented disease progression at the end of a treatment visit who have not yet started treatment with another anti-cancer therapy will proceed with monthly follow-up visits until initiation of another anti-cancer therapy, disease progression, or study cut-off date, whichever comes first.

Clinical Study Identifier: NCT03594955

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Recruitment Status: Open

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