Overview

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

Status:
Terminated
Trial end date:
2021-01-05
Target enrollment:
Participant gender:
Summary
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.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
Sanofi