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

Stopped early · Phase 1/Phase 2

Conditions studied: Leukaemia

In brief

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.

Key facts

Study ID

NCT03594955

Run by

Sanofi

People needed

7

Starts

2018-10-24

Expected to finish

2021-02-06

Last updated by the study team

2022-05-24

Who can join

Age: 16 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Confirmed diagnosis of Acute Myeloblastic leukemia (AML) (except acute promyelocytic leukemia), or myelodysplastic syndrome (MDS) with a risk category of intermediate or higher. Participants must had exhausted available treatment options and might not be eligible for any treatment known to provide clinical benefit.
• Participants with AML must had relapsed or refractory disease that had been resistant to available therapies.
• Participants with B-ALL (B acute lymphoid leukemia) in second or subsequent relapse: should had completed previously greater than or equal to (>=) 1 cycle of a salvage regimen. Participants must had exhausted available treatment options and must not be eligible for any treatment known to provide clinical benefit.
• Participants with HR-MDS (high risk myelodysplastic syndrome) must have greater than (>) 10 percentage blasts in the bone marrow at the time of enrollment and fit one of the following categories: Not eligible for induction therapy and having completed >=2 cycles of therapy or not eligible for allogeneic stem cell transplant and had completed >=1 course of induction therapy.
• Signed written informed consent.

You may not qualify if…

• Aged less than 16 years old.
• Eastern Cooperative Oncology Group (ECOG) performance status >2.
• Participants with inadequate biological tests.
• White blood cell count > 30,000 per cubic millimeter.
• History of active or chronic autoimmune conditions that had required or requires therapy.
• Graft-versus-host disease following allogeneic stem cell transplantation required treatment with more than 10 milligrams (mg) of oral prednisone or equivalent daily. The stem cell transplant and/or donor lymphocyte infusion should had been performed more than 3 months before study treatment start.
• Second primary malignancy that required active therapy. Adjuvant hormonal therapy was allowed.
• Previous treatment with radiotherapy or immunotherapeutic agents in the 4 weeks prior to investigational medicinal product (IMP) administration.
• Previous treatment with any other investigational agent in the 4 weeks prior to IMP administration.
• Receiving, at the time of first IMP administration, of concurrent steroids >10 mg per day of oral prednisone or the equivalent for >=3 months.
• Requirement for tocilizumab for any other diagnosis.
• Evidence of active central nervous system leukemia at the time of enrollment.
• Acquired immunodeficiency syndrome (AIDS-related illnesses) or human immunodeficiency virus disease requiring antiretroviral treatment or had active Hepatitis B viral infection or Hepatitis C viral infection.
• Women of childbearing potential, male with a partner of childbearing potential who did not agree to use effective methods of birth control.
• Any clinically significant, uncontrolled medical conditions that, in the Investigator's opinion, would expose excessive risk to the participant or may interfere with compliance or interpretation of the study results.
• The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Where it is running

• Investigational Site Number 8400001 — Houston, Texas, United States
• Investigational Site Number 2500004 — Marseille, France
• Investigational Site Number 2500001 — Paris, France
• Investigational Site Number 2500003 — Villejuif, France

Full record on ClinicalTrials.gov

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