samuraciclib + giredestrant

Samuraciclib + giredestrant is an oral combination therapy co-developed by Carrick Therapeutics and Roche for the treatment of hormone receptor-positive, HER2-negative (HR+/HER2-) metastatic breast cancer, specifically targeting patients who have developed resistance to CDK4/6 inhibitors. The combination consists of samuraciclib (CT7001), a first-in-class, selective inhibitor of cyclin-dependent kinase 7 (CDK7), and giredestrant (GDC-9545), a potent, non-steroidal selective estrogen receptor degrader (SERD). CDK7 is a critical regulator of both the cell cycle and RNA polymerase II-mediated transcription; its inhibition by samuraciclib is intended to disrupt oncogenic signaling and overcome resistance mechanisms. Giredestrant works by binding to and inducing the degradation of the estrogen receptor. Clinical evidence from the MORPHEUS umbrella trial indicates that the combination may be particularly effective in patients with wild-type TP53, leading to a biomarker-driven development strategy for future Phase 3 trials.

Other names

CT7001 + GDC-9545MORPHEUS combinationsamuraciclib and giredestrant