BOSTON - Carrick Therapeutics, a biopharmaceutical company specializing in oncology, has commenced a Phase 1b/2 clinical trial for a novel combination therapy aimed at treating a specific type of metastatic breast cancer. The trial involves samuraciclib and vepdegestrant, targeting estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+/HER2-) breast cancer in patients who have previously undergone CDK4/6 inhibitor therapy.
The first patient has been dosed in the trial, marking a significant step in the development of these therapies. Samuraciclib, developed by Carrick, is an oral CDK7 inhibitor, while vepdegestrant, co-developed by Arvinas and Pfizer (NYSE:PFE), is an oral estrogen receptor degrader employing PROTAC technology.
The clinical trial, identified as TACTIVE-U and listed under study ID NCT06125522, is structured in two segments. The initial phase will focus on establishing the appropriate dosages for the combination therapy, while the subsequent phase will evaluate the safety and efficacy of the established doses in a broader patient group.
Tim Pearson, CEO of Carrick Therapeutics, expressed optimism regarding the potential of the combination treatment, citing initial encouraging data for vepdegestrant and Pfizer's expertise in breast cancer treatments.
Vepdegestrant has shown promising results in preclinical studies, with up to 97% estrogen receptor degradation in tumor cells and significant tumor shrinkage as a single agent. It has also demonstrated enhanced anti-tumor activity compared to fulvestrant, a standard care agent, both alone and in combination with a CDK4/6 inhibitor.
Samuraciclib has been granted Fast Track designation by the U.S. FDA for use in combination with fulvestrant for CDK4/6i resistant HR+, HER2- advanced breast cancer. Carrick is also exploring samuraciclib's potential in other cancers and is collaborating with Roche, Menarini Group, and Arvinas/Pfizer for further combination studies.
This clinical trial is a part of a larger collaboration between Arvinas and Pfizer, which includes shared development costs, commercialization expenses, and profits. The trial's progress will continue to be monitored for safety and anti-tumor efficacy.
The information for this article is based on a press release statement.
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