18 Oct 2023
Carrick Therapeutics Announces First Patient Dosed in Phase 2 Clinical Trial of Samuraciclib in Combination with Elacestrant in Patients with Advanced Breast Cancer
BOSTON, Oct. 18, 2023 (GLOBE NEWSWIRE) — Carrick Therapeutics, an oncology-focused biopharmaceutical company discovering and developing highly differentiated therapies, today announced that the first patient has been dosed in its Phase 2 clinical trial evaluating the novel combination of Carrick’s samuraciclib (CT7001), an oral and first-in-class inhibitor of CDK7, and the Menarini Group’s (Menarini) oral selective estrogen receptor degrader (SERD), elacestrant, in patients with CDK4/6i resistant HR+, HER2- metastatic breast cancer.
“Dosing the first patient in our Phase 2 clinical trial evaluating the combination of samuraciclib and elacestrant is an important milestone in our goal of improving outcomes for women fighting metastatic breast cancer,” said Tim Pearson, Chief Executive Officer of Carrick Therapeutics. “Our prior studies have validated the biology for elacestrant with CDK7, and we are eager to evaluate the potential synergistic benefit of this fully oral combination therapy in patients with advanced breast cancer.”
The trial will initially evaluate the tolerability and pharmacokinetics of the combination then recruit an expansion cohort evaluating the longer-term progression free survival benefits. ctDNA analysis performed via liquid biopsy will form a critical component of the study to inform two key questions: (1) the level of benefit in patients without a detectable ESR1-mutation and (2) the patient selection biomarker potential of TP53-mutation status.
The Phase 2 clinical trial evaluating the novel combination of samuraciclib and elacestrant is being conducted in collaboration with Menarini, pursuant to a clinical trial collaboration and supply agreement for elacestrant. Clinical trial details can also be found on www.clinicaltrials.gov under study ID: NCT05963997. For additional information on the clinical trial, please contact email@example.com.