Carrick Therapeutics, a biopharmaceutical firm specializing in oncology, has initiated a Phase 1b/2 clinical trial to test the efficacy and safety of a combined treatment of samuraciclib (CT7001) and vepdegestrant (ARV-471) in patients with ER+, HER2- metastatic breast cancer who have already been treated with a CDK4/6 inhibitor. Samuraciclib is a novel CDK7 inhibitor, while vepdegestrant is a PROTACestrogen receptor degrader co-developed by Arvinas and Pfizer. The trial, which is part of the TACTIVE-U study, will first establish the optimal dosages of both drugs before expanding to further assess their combined impact on patient outcomes.
The company's CEO, Tim Pearson, expressed optimism about the potential of this treatment combination, citing positive preliminary data and Pfizer's expertise in breast cancer treatments. The clinical trial is registered on www.clinicaltrials.gov with the identifier NCT06125522. Vepdegestrant has shown significant ER degradation and tumor reduction in preclinical models and is being co-developed by Arvinas and Pfizer, who share development costs and profits equally.
Samuraciclib, which has received Fast Track designation from the FDA, is being studied for its potential in various cancer types beyond breast cancer. Carrick Therapeutics is also developing CT7439, another novel therapeutic targeting CDK12/13.
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