Pharma Focus Asia

Carrick Therapeutics Initiates Phase 1b/2 Clinical Trial Treating Advanced Breast Cancer Patients with Samuraciclib in Combination with Vepdegestrant: First Patient Dosed

Thursday, February 15, 2024

Carrick Therapeutics, a company specializing in oncology treatments, has announced the initiation of its Phase 1b/2 clinical trial, marking the dosing of the first patient. This trial aims to evaluate the combination of samuraciclib (CT7001), an investigational CDK7 inhibitor, and vepdegestrant (ARV-471), an investigational oral estrogen receptor degrader, in women with ER+, HER2- metastatic breast cancer who have previously received a CDK4/6 inhibitor.

Tim Pearson, CEO of Carrick Therapeutics, expressed enthusiasm about the trial, highlighting its importance in addressing the needs of advanced breast cancer patients. Pearson emphasized the potential of this combination treatment, citing promising initial data for vepdegestrant and Pfizer's expertise in breast cancer therapeutics.

The Phase 1b/2 trial comprises two parts: Phase 1b involves testing escalating doses of both samuraciclib and vepdegestrant to determine optimal combination dosages, while Phase 2 will enroll additional patients to further assess safety and efficacy.

This clinical trial is part of the TACTIVE-U study, conducted in collaboration with Arvinas and Pfizer under a clinical trial collaboration and supply agreement.

Vepdegestrant (ARV-471) is an investigational PROTAC protein degrader designed to target and degrade the estrogen receptor for the treatment of ER+/HER2- breast cancer. Preclinical studies have shown significant tumor shrinkage and enhanced anti-tumor activity compared to standard agents.

Samuraciclib (CT7001) is a leading CDK7 inhibitor in clinical development, showing promising safety and efficacy profiles in early studies. It has been granted Fast Track designation by the FDA for use in combination with fulvestrant in advanced breast cancer.

Carrick Therapeutics is collaborating with Roche, Menarini Group, and Arvinas/Pfizer to explore novel combinations of samuraciclib with other therapies in late-stage CDK4/6 inhibitor-resistant breast cancer.



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