Schéma : Primary Objectives:
- Dose Escalation: Part A (SAR439859 monotherapy); Part C (combination of SAR439859 with palbociclib)
- To determine the maximum tolerated dose (MTD) and recommended dose (RD) of SAR439859 based on the dose-limiting toxicity (DLT) observance in monotherapy (Part A), and in combination with palbociclib (Part C)
- Dose Expansion: Part B (SAR439859 monotherapy); Part D (combination SAR439859 with palbociclib)
- To assess antitumor activity by Objective Response Rate (ORR) at the SAR439859 recommended dose in monotherapy (Part B), and in combination with palbociclib (Part D)
Secondary Objectives:
- Overall safety profile of SAR439859 as monotherapy (Parts A, B), and in combination with palbociclib (Parts C, D)
- Pharmacokinetic (PK) profile of SAR439859 as monotherapy (Parts A, B), and of SAR439859 in combination with palbociclib (Parts C, D), and of palbociclib in combination with SAR439859 (Parts C, D)
- Antitumor activity of SAR439859 as monotherapy (Part A), and in combination with palbociclib (Part C) as well as the Clinical Benefit Rate (CBR: Complete Response [CR], Partial Response [PR] and Stable Disease [SD] ≥24 weeks) in Parts A, B, C, and D
- ORR and CBR (CR, PR and SD ≥24 weeks) according to the estrogen receptor 1 (ESR1) gene mutational status (mutant and wild type) at baseline and in treatment
- Time to first tumor response (CR or PR) in Parts B and D
- Residual estrogen receptor (ER) availability with [(18)F] Fluoroestradiol Positron Emission Tomography (FES PET) scan (Part A)
Phase : I/II
Stade : Localement avancé à Métastatique
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