Phase 1 / 2 Study of Amcenestrant (SAR439859) Single Agent and in Combination With Other Anti-cancer Therapies in Postmenopausal Women With Estrogen Receptor Positive Advanced Breast Cancer

• Status: Recruiting
• Trial end date: 2024-01-01

Summary

Primary Objectives:

Dose Escalation:

• To assess the incidence rate of dose-limiting toxicity (DLT) and to determine the maximum tolerated dose (MTD) as well as the recommended dose (RD) of amcenestrant administered as monotherapy and in combination with palbociclib

• To assess the incidence rate of DLT and determine the RD of everolimus or abemaciclib in combination with the selected amcenestrant dose for the combination therapy

Safety Run-In:

• To confirm the RD of amcenestrant in combination with alpelisib

Dose Expansion:

• Antitumor activity using objective response rate (ORR)

• Overall safety profile of amcenestrant administered in combination with palbociclib, alpelisib, everolimus, and abemaciclib

Secondary Objectives:

• Overall safety profile of amcenestrant monotherapy and in combination

• Pharmacokinetic (PK) profile of amcenestrant administered as monotherapy or in combination and PK profile of palbociclib, alpelisib, everolimus and abemaciclib

• Antitumor activity using ORR, the clinical benefit rate (CBR) and progression free survival (PFS)

• Time to first tumor response

• Residual ER availability with positron emission tomography (PET) scan [(18)F] fluoroestradiol (18F-FES) uptake with increasing doses of amcenestrant

• Food effect on PK of amcenestrant

• Potential induction/inhibition effect of amcenestrant on cytochrome P450 (CYP) 3A using 4b-OH cholesterol

• Phase: Phase 1/Phase 2

Details

• Lead Sponsor: Sanofi
• Treatments: Estrogens; Everolimus; Palbociclib