Skip to main content
Premium Trial:

Request an Annual Quote

Carrick Therapeutics Begins Phase Ib/II Trial of CDK7 Inhibitor Combination in Breast Cancer

NEW YORK – Carrick Therapeutics on Wednesday said it dosed the first patient in a Phase Ib/II trial of its CDK7 inhibitor samuraciclib with the estrogen receptor degrader vepdegestrant in patients with estrogen receptor-positive, HER2-negative metastatic breast cancer who have previously received a CDK4/6 inhibitor.

In the Phase Ib portion of the trial, which is a sub-study within the TACTIVE-U umbrella trial, patients will receive escalating doses of samuraciclib and Arvinas and Pfizer's vepdegestrant to determine a recommended Phase II dose. In the Phase II portion of the trial, the investigators will expand the trial to further explore the safety and efficacy of the drug combination at selected doses. The trial's primary endpoints will be dose-limiting toxicities, drug-drug interactions, and objective response rate. The researchers will also track anti-tumor activity of samuraciclib, duration of response, progression-free response, and other measures of pharmacokinetics, safety, and efficacy as secondary endpoints.

"We believe there is great potential for this combination treatment, based on the encouraging initial clinical trial data for vepdegestrant and Pfizer's deep expertise in developing treatments for breast cancer," Carrick CEO Tim Pearson said in a statement.

Under the terms of a clinical trial collaboration and supply agreement between Carrick, Arvinas, and Pfizer, Arvinas will lead regulatory activities for the study in the US and Pfizer will lead developmental efforts in the US. Outside the US, Pfizer will be responsible for both the regulatory and development activities.

The Boston-based company recently launched a Phase IIb trial of samuraciclib with fulvestrant in hormone receptor-positive, HER2-negative, advanced breast cancer in which it is evaluating the safety and efficacy of the combination treatment in patients who have progressed on a CDK4/6 inhibitor and aromatase inhibitor combination. It is also studying samuraciclib with Menarini Group's oral selective estrogen receptor degrader Orserdu (elacestrant) in patients with HR-positive, HER2-negative metastatic breast cancer who are resistant to a CDK4/6 inhibitor, and it is studying the drug in the same setting with Roche's SERD giredestrant.