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Carrick Therapeutics Launches Phase 2b Trial of Samuraciclib with Fulvestrant in Advanced HR+, HER2- Breast Cancer

Saturday, December 16, 2023

Carrick Therapeutics, a biopharmaceutical company focused on oncology, has initiated its Phase 2b clinical trial for the combination of samuraciclib (CT7001) and fulvestrant in women diagnosed with HR+, HER2- advanced breast cancer who have previously undergone CDK4/6 inhibitor treatment. Samuraciclib, an oral CDK7 inhibitor, is being investigated alongside fulvestrant, a selective estrogen receptor degrader (SERD) administered intramuscularly.

Tim Pearson, the CEO of Carrick Therapeutics, expressed satisfaction with the progress, citing the substantial unmet need for HR+, HER2- breast cancer treatment. The Phase 2a study demonstrated promising clinical activity and tolerability for the samuraciclib-fulvestrant combination, prompting optimism about its potential as a leading therapy for advanced breast cancer.

The ongoing randomized Phase 2b trial aims to assess the Progression-Free Survival benefit of combining samuraciclib with fulvestrant compared to fulvestrant alone in patients whose breast cancer progressed after CDK4/6 inhibitor treatment.

Pfizer Ignite is providing support for the trial through its comprehensive service for biotech companies. Carrick maintains complete ownership of samuraciclib and its pipeline.

Samuraciclib, the most advanced CDK7 inhibitor, shows promise in cancer therapy by regulating cancer-causing gene transcription, controlling cell cycle progression, and combating resistance to anti-hormone therapy. The drug has received Fast Track designation from the FDA for use with fulvestrant in CDK4/6 inhibitor-resistant HR+, HER2- advanced breast cancer.

Carrick is collaborating with Roche, Menarini Group, and Arvinas/Pfizer to explore combinations of samuraciclib with Roche's oral SERD giredestrant, Menarini Group's oral SERD elacestrant, and Arvinas/Pfizer's PROTAC Estrogen Receptor degrader vepdegestrant (ARV-471) in late-stage CDK4/6 inhibitor-resistant HR+, HER2- metastatic breast cancer.



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