Carrick to execute Phase 2 clinical trial in patients with CDK4/6i resistant HR+, HER2- metastatic breast cancer

Carrick Therapeutics, an oncology-focused biopharmaceutical company discovering and developing highly differentiated therapies, and the Menarini Group ("Menarini"), a privately-held, leading international pharmaceutical company, today announced a clinical trial collaboration and supply agreement.

This agreement covers the execution of a Phase 2 clinical trial to evaluate the novel combination of Carrick's samuraciclib (CT7001), an oral and first-in-class inhibitor of CDK7, and Menarini's oral selective estrogen receptor degrader (SERD), elacestrant, in patients with CDK4/6i resistant HR+, HER2- metastatic breast cancer. Menarini and Carrick will jointly sponsor the clinical trial.

"We are excited to initiate this collaboration with Menarini to explore the potential of samuraciclib in combination with elacestrant for the treatment of advanced breast cancer," said Tim Pearson, Chief Executive Officer of Carrick Therapeutics. "Our pre-clinical work and prior clinical studies have validated the biology for SERD combinations with CDK7, pointing to potential synergies when combining samuraciclib with Menarini's oral SERD, elacestrant. This collaboration represents a shared commitment to maximizing the potential of novel combination therapies to improve outcomfes for people living with breast cancer."

"This new clinical collaboration with Carrick Therapeutics is yet another step we are making to develop elacestrant in an extensive way to address unmet needs of patients resistant to CDK4/6 therapies in HR+, HER2- metastatic breast cancer," said Elcin Barker Ergun, Chief Executive Officer of Menarini. "Menarini will continue to pursue research collaborations that have the potential to improve patients' lives in breast cancer." 

Carrick anticipates initiating the Phase 2 clinical trial in 2023. This new study will expand Carrick's portfolio of ongoing clinical trials with samuraciclib. The company presented encouraging results from a clinical study combining samuraciclib with fulvestrant at the 2021 San Antonio Breast Cancer Symposium.