SNDX-275-0602 is a Phase 1b/2 study evaluating the combination of entinostat plus atezolizumab in patients with aTNBC. The study has 2 phases: an open-label Dose Determination Phase (Phase 1b) followed by an Expansion Phase (Phase 2). The Expansion Phase will evaluate the efficacy and safety of entinostat when administered at the RP2D with atezolizumab in patients with aTNBC in a randomized, double-blind, placebo-controlled setting. Up to 88 evaluable patients are anticipated if the study completes all phases of evaluation (up to 18 patients for Phase 1b, up to 70 patients for Phase 2). Up to 30 study centers in the US and Europe may participate.~Safety will be assessed during the study by documentation of AEs, clinical laboratory tests, physical examinations, vital sign measurements, electrocardiograms (ECGs), and Eastern Cooperative Oncology Group (ECOG) performance status. Adverse events of special interest (AESI) will be collected and reviewed in a manner consistent with serious adverse event reporting procedures.
The purpose of this study is to determine the safety and tolerability of entinostat used in combination with atezolizumab in patients with Advanced Triple Negative Breast Cancer (aTNBC). Additionally, the purpose of the study is to assess how effective entinostat and atezolizumab are in combination in patients with aTNBC.