R Charles Coombes, Sacha Howell, Simon R Lord, Laura Kenny, Janine Mansi, Zahi Mitri, Carlo Palmieri, Linnea I Chap, Paul Richards, William Gradishar, Sagar Sardesai, Jason Melear, Joyce O'Shaughnessy, Patrick Ward, Pavani Chalasani, Tobias Arkenau, Richard D Baird, Rinath Jeselsohn, Simak Ali, Glen Clack, Ashwani Bahl, Stuart McIntosh, Matthew G Krebs
Samuraciclib is a selective oral CDK7-inhibitor. A multi-modular, open-label Phase I study to evaluate safety and tolerability of samuraciclib in patients with advanced malignancies was designed (ClinicalTrials.gov: NCT03363893). Here we report results from dose escalation and 2 expansion cohorts: Module 1A dose escalation with paired biopsy cohort in advanced solid tumor patients, Module 1B-1 triple negative breast cancer (TNBC) monotherapy expansion, and Module 2A fulvestrant combination in HR+/HER2- breast cancer patients post-CDK4/6-inhibitor...
July 24, 2023: Nature Communications