NEW YORK – The Canadian Cancer Trials Group on Monday said that it has opened a new protocol involving Treadwell Therapeutics' investigational PLK4 inhibitor, CFI-400945, within an ongoing Phase II umbrella trial.
The Prostate Cancer Biomarker Enrichment and Treatment Selection (PC-BETS) Study is an umbrella trial evaluating biomarker-matched treatments for metastatic castration-resistant prostate cancer (mCRPC) patients. The trial, sponsored by the Canadian Cancer Trials Group, the Canadian Cancer Clinical Trials Network, and BC Cancer Foundation, will enroll roughly 500 patients with mCRPC and match them to treatments, such as targeted drugs, immunotherapy agents, or chemotherapy, based on liquid biopsy-based biomarker evaluation. Specifically, the biomarkers will be identified from cell-free DNA in patients' plasma samples.
The primary aim of the umbrella trial is to evaluate outcomes across the treatment arms based on various parameters, including the proportion of patients whose prostate-specific antigen levels decline over 50 percent, complete or partial response rates, and the 12-week stable disease rate.
Treadwell's CFI-400945 is designed to inhibit PLK4, which is overexpressed in different cancer types and is associated with poor outcomes. CFI-400945 has demonstrated anti-tumor activity in preclinical research, and the New York-based drug development firm plans to evaluate it further as a single agent and in combination with PDL-L1/ PD-1 inhibitors in a variety of hematologic and solid tumors.
"We are very excited to see the initiation of this [umbrella] trial that builds on preclinical work demonstrating an association between loss of the tumor suppressor PTEN, a common alteration in this disease setting, and response to CFI-400945," Treadwell CSO and Co-founder Mark Bray said in a statement.