Primary Objective: Participants achieving an Objective Response Rate Secondary Objectives: * Response duration * Progression Free Survival * Minimal residual disease * Safety * Pharmacokinetics
The duration of the study for an individual patient will include: * The screening period = up to 4 weeks prior to the first administration of SAR3419. * The treatment period: * Induction period = 4 to 8 weeks * Maintenance = up to a total maintenance treatment of 6 months * A safety follow-up period of 42 days after the last dose. * Any patient who discontinues the study treatment without disease progression will be followed every 2 months until disease progression, initiation of a new anti-cancer therapy, death or end-of-study date, whatever comes first.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Pharmaceutical form: concentrate solution for infusion Route of administration: intravenous
Investigational Site Number 840006
Denver, Colorado, United States
Investigational Site Number 840003
Nashville, Tennessee, United States
Investigational Site Number 840001
Houston, Texas, United States
Number of participants achieving an Objective Response Rate
Time frame: 4 to 8 weeks
Number of participants with Adverse Events
Time frame: Up to 1 year
Assessment of PK parameter - maximum concentration (Cmax)
Time frame: Up to 8 months
Assessment of PK parameter - area under curve (AUC)
Time frame: Up to 8 months
Assessment of PK parameter - half-life (T1/2)
Time frame: Up to 8 months
Assessment of PK parameter - clearance
Time frame: Up to 8 months
Assessment of PK parameter - volume in steady state (Vss)
Time frame: Up to 8 months
Assessment of minimal residual disease (MRD)
Time frame: 4 to 8 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Investigational Site Number 840002
San Antonio, Texas, United States
Investigational Site Number 840004
Milwaukee, Wisconsin, United States
Investigational Site Number 250006
Amiens, France
Investigational Site Number 250001
Paris, France
Investigational Site Number 250002
Pessac, France
Investigational Site Number 250008
Pierre-Bénite, France
Investigational Site Number 250004
Rennes, France
...and 1 more locations