First in Human Testing of Dose-escalation of SAR440234 in Patients With Acute Myeloid Leukemia, Acute Lymphoid Leukemia and Myelodysplastic Syndrome
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|ClinicalTrials.gov Identifier: NCT03594955|
Recruitment Status : Recruiting
First Posted : July 20, 2018
Last Update Posted : September 17, 2020
- 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.
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Leukaemia||Drug: SAR440234||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||77 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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)|
|Actual Study Start Date :||October 24, 2018|
|Estimated Primary Completion Date :||February 2023|
|Estimated Study Completion Date :||February 2023|
SAR440234 as weekly intravenous injection; a cycle is defined as 6 weeks of study treatment; (Additionally infusion on day 4 is planned for dose level ≥ 3). One dose escalation scheme will be used. Treatment may be continued as long as it is clinically beneficial.
Pharmaceutical form:lyophilisate to be resuspended in solution Route of administration: intravenous
- Incidence of Dose-limiting toxicities (DLTs) [ Time Frame: Baseline to Day 42 ]Incidence of DLTs observed, using NCI-CTCAE v4.03 or 2014 NCI Consensus Guidelines for cytokine release syndrome, during the first 42 days following the first administration of IMP in the first cycle of treatment.
- Incidence of allergic reactions/hypersensitivity and CRS/acute infusion reactions [ Time Frame: Baseline to 30 days after last study treatment administration ]Incidence of allergic reactions/hypersensitivity and CRS/acute infusion reactions
- Overall response rate (ORR) [ Time Frame: Baseline to 30 days after last study treatment administration ]ORR is defined as the proportion of patients with complete response (CR), CRi, and partial response (PR).
- Duration of response (DOR) [ Time Frame: Baseline to date of first documentation of disease progression ]DOR is defined as the time from the date of the first response (≥PR) that is subsequently confirmed to the date of first confirmed disease progression or death, whichever happens first.
- Event-free survival [ Time Frame: Baseline to date of first documentation of disease progression ]Event-free survival is defined as time from the first study treatment administration to the date of first documentation of progressive disease that is subsequently confirmed or the date of death from any cause.
- Adverse events [ Time Frame: Baseline to 30 days after last study treatment administration ]Number of adverse events.
- Preliminary Anti-leukemia Activity [ Time Frame: Baseline to approximately 3 months after the last entered patient ]Preliminary anti-leukemia activity as defined by IWG for MDS or AML or National Comprehensive Cancer Network (NCCN) for B-ALL. (Dose escalation part).
- Immunogenicity of SAR440234 [ Time Frame: Baseline to approximately 3 months after the last entered patient ]Anti-SAR440234 Antibodies (ADA) incidence is defined as the proportion of patients found to either have treatment induced ADA or boosted their pre-existing ADA response during the study.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03594955
|Contact: Trial Transparency email recommended (Toll free number for US & Canada)||800-633-1610 ext 1 then #||Contact-US@sanofi.com|
|United States, Texas|
|Investigational Site Number 8400001||Recruiting|
|Houston, Texas, United States, 77030|
|Investigational Site Number 2500004||Recruiting|
|Marseille, France, 13273|
|Investigational Site Number 2500001||Recruiting|
|Paris Cedex 10, France, 75010|
|Investigational Site Number 2500003||Recruiting|
|Villejuif Cedex, France, 94805|
|Study Director:||Clinical Sciences & Operations||Sanofi|