Phase 2 Trial Launched to Test CFI-400945 Plus Imfinzi in Advanced TNBC



The Canadian Cancer Trials Group (CCTG) has launched a Phase 2 study of CFI-400945 in combination with Imfinzi (durvalumab) for the treatment of advanced or metastatic triple negative breast cancer (TNBC).

CFI-400945 is an investigational compound that stops cell division by inhibiting a protein called polo-like kinase 4.

Because unchecked cell division is a hallmark of cancer cells, blocking it may kill these cells or slow their growth.

Imfinzi, developed by AstraZeneca, is a type of immunotherapy called an immune checkpoint inhibitor that prevents a protein called PD-L1 from interacting with the PD-1 receptor in immune cells. Cancer cells often use this interaction to evade immune attacks.

“Immunotherapy in combination with chemotherapy has shown promise in this disease; however, non-chemotherapy combinations which avoid those toxicities and may have activity in the chemorefractory setting are of particular interest,” said David Cescon, MD, medical oncologist at Princess Margaret Cancer Centre (PMCC), and Andrew G. Robinson, MD, of Queen’s University, both co-chairs of the study, in a press release.

The trial (NCT04176848) primarily aims to assess the efficacy of the combination therapy, as measured by the proportion of patients whose tumors decrease in size by a predefined amount — called the objective response rate — over a two-year period.

Secondary endpoints include the percentage of patients who achieve complete or partial response and stable disease (called the disease control rate), the immune-related response rate, and safety and tolerability of the medications, among others.

The trial seeks to enroll approximately 28 female patients, 18 years or older, who will receive Imfinzi given intravenously (through the vein) and CFI-400945 as an oral medicine.

Participating centers will include the PMCC, Ottawa Hospital Research Institute, and Kingston Health Sciences Centre, in Ontario, Canada.

Recruitment is open, and more information can be found here.

CFI-400945 is also being tested in several other trials for different cancers, including prostate cancer and acute myeloid leukemia.

“The [P]hase 1 clinical trial of CFI-400945 demonstrated anti-tumor activity, while non-clinical studies conducted at the PMCC showed activity of CFI-400945 in TNBC models, which appears to be increased in immune competent models in combination with checkpoint blockade,” said Lesley Seymour, MD, PhD, director of CCTG’s Investigational New Drug Program.

The CCTG is a cooperative oncology group that designs and administers clinical trials in cancer therapy, supportive care, and prevention in more than 80 institutions across Canada and internationally.

The study is supported as part of a collaboration between the CCTG and AstraZeneca, with CFI-400945 provided by Treadwell Therapeutics.

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