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: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi

Criteria

Inclusion criteria :

• Confirmed diagnosis of Acute Myeloblastic leukemia (AML) (except acute promyelocytic leukemia), or myelodysplastic syndrome (MDS) with a risk category of intermediate or higher. Patients must have exhausted available treatment options and must not be eligible for any treatment known to provide clinical benefit.

• Patients with AML must have relapsed or refractory disease that has been resistant to available therapies.

• Patients with B-ALL (B acute lymphoid leukemia) in second or subsequent relapse:

should have completed previously ≥1 cycle of a salvage regimen. Patients must have exhausted available treatment options and must not be eligible for any treatment known to provide clinical benefit.

• Patients with HR-MDS (high risk myelodysplastic syndrome) must have >10% 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 having completed ≥1 course of induction therapy.

• Signed written informed consent.

Exclusion criteria:

• Age <16 years old.

• Eastern Cooperative Oncology Group (ECOG) performance status >2.

• Patients with inadequate biological tests.

• White blood cell count > 30,000/mm3

• History of active or chronic autoimmune conditions that has required or requires therapy.

• Graft-versus-host disease following allogeneic stem cell transplantation requiring treatment with more than 10 mg of oral prednisone or equivalent daily. The stem cell transplant and/or donor lymphocyte infusion should have been performed more than 3 months before study treatment start.

• Second primary malignancy that requires active therapy. Adjuvant hormonal therapy is 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/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 HIV (human immunodeficiency virus) disease requiring antiretroviral treatment or having active Hepatitis B viral infection or Hepatitis C viral infection.

• Women of childbearing potential, male with a partner of childbearing potential who do 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 patient or may interfere with compliance or interpretation of the study results.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.