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

Leukaemia Clinical Trial

Official title: An Open-label, First-in-human, Dose Escalation Study of SAR440234 Administered as Single Agent by Intravenous Infusion in Patients With Relapsed or Refractory Acute Myeloid Leukemia (R/R AML), B-cell Acute Lymphoblastic Leukemia (B-ALL), or High Risk Myelodysplasia (HR-MDS)

Status Terminated

Clinical Trial Summary

Primary Objective:

• Dose escalation: To determine the maximum tolerated dose (MTD) of SAR440234 administered as a single agent in participants with relapsed or refractory acute myeloid leukemia (R/R AML), high risk myelodysplastic syndrome (HR-MDS), or B-cell acute lymphoblastic leukemia (B-ALL), 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 participants 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.

Clinical Trial Description

The duration of the study for the participants included a period for screening of up to 14 days. The cycle duration was 42 days. Participants continued study treatment as long as clinical benefit was possible or until disease progression, unacceptable adverse reaction, participant's decision to stop treatment, or other reason of discontinuation. After study treatment discontinuation participants returned to the study site 30 days after the last administration of SAR440234 for end of treatment assessments. Participants without documented disease progression at the end of a treatment visit who had not yet started treatment with another anti-cancer therapy would proceed with monthly follow-up visits until initiation of another anti-cancer therapy, disease progression, or study cut-off date, whichever came first. ;

Related Conditions & MeSH terms

• Leukaemia
• Leukemia
• Leukemia, Myeloid, Acute

• NCT number: NCT03594955
• Study type: Interventional
• Source: Sanofi
• Status: Terminated
• Phase: Phase 1/Phase 2
• Start date: October 24, 2018
• Completion date: February 6, 2021