Phase 1b/2 Trial Initiated: Samuraciclib Combined with Vepdegestrant for Advanced Breast Cancer

Carrick Therapeutics, a biopharmaceutical firm specializing in oncology, has commenced a Phase 1b/2 clinical trial to assess the efficacy and safety of a combined therapy involving samuraciclib (CT7001) and vepdegestrant (ARV-471) for patients with ER+, HER2- metastatic breast cancer who have previously undergone treatment with a CDK4/6 inhibitor. Samuraciclib is an innovative oral CDK7 inhibitor, while vepdegestrant is an oral PROTAC® estrogen receptor degrader co-developed by Arvinas and Pfizer.
The trial, led by Tim Pearson, CEO of Carrick Therapeutics, aims to build upon promising initial data for vepdegestrant and leverage Pfizer's expertise in breast cancer treatment development. The study is divided into two phases: Phase 1b will establish the optimal dosages of both drugs when used in tandem, and Phase 2 will involve more participants to further investigate the treatment's safety and effectiveness.
The collaboration with Arvinas and Pfizer is conducted under a clinical trial agreement, and more details can be accessed on www.clinicaltrials.gov with the study ID: NCT06125522. Vepdegestrant, the investigational compound, has shown significant ER degradation and tumor reduction in preclinical models, outperforming the standard fulvestrant in both solo and combined use with a CDK4/6 inhibitor. Arvinas and Pfizer have entered a global partnership for the development and commercialization of vepdegestrant, sharing development costs, commercialization expenses, and profits.
Samuraciclib, the most advanced CDK7 inhibitor in clinical trials, has demonstrated a good safety profile and potential in treating various cancers, including breast, prostate, pancreatic, ovarian, and colorectal. It has received Fast Track designation from the FDA for use in combination with fulvestrant for HR+, HER2- advanced breast cancer. Carrick is also exploring combinations of samuraciclib with other therapies for late-stage CDK4/6i resistant HR+, HER2- metastatic breast cancer.
Carrick Therapeutics is dedicated to developing novel therapies for significant unmet needs in oncology, with samuraciclib as its leading program in Phase 2 trials for HR+ breast cancer. The company is also advancing CT7439, a CDK12/13 inhibitor/Cyclin-K degrader, expected to enter Phase 1 trials in mid-2024.