Cardiff Oncology, Inc. (Nasdaq: CRDF), a US-based clinical-stage biotechnology company, announced on Tuesday that it has dosed its first subject with its investigational drug onvansertib in its Phase two ONSEMBLE trial (NCT05593328).

The trial is aimed at showcasing a clinically meaningful difference in response and onvansertib's contribution to standard of care (SoC) FOLFIRI/bevacizumab for the second line treatment of subjects with KRAS/NRAS-mutated metastatic colorectal cancer (mCRC).

The Phase 2 ONSEMBLE trial is conducted in subjects with mCRC who have a documented KRAS or NRAS mutation and have earlier received one prior chemotherapy regimen with or without bevacizumab in the first line metastatic setting. Subjects are being randomised to onvansertib and FOLFIRI/bevacizumab compared to FOLFIRI/bevacizumab (standard of care).

Heinz-Josef Lenz, MD, USC Norris Comprehensive Cancer Center, is heading the trial. He has experience with the firm's mCRC clinical program, having served as the principal investigator for the Phase 1b/2 trial.