A Phase II trial to investigate onvansertib for the second line treatment of patients with KRAS/NRAS-mutated metastatic colorectal cancer (mCRC) has treated its first patients.
The ONSEMBLE trial is designed to demonstrate a clinically meaningful difference in response and onvansertib’s contribution to standard of care (SoC) FOLFIRI/bevacizumab.
“We are excited to be underway with our ONSEMBLE trial that builds on the promising efficacy and tolerability results demonstrated in our Phase Ib/II trial in mCRC,” said Fairooz Kabbinavar, Chief Medical Officer of Cardiff Oncology.
“mCRC is a difficult-to-treat cancer and patients in the second line setting need novel therapeutic options to improve clinical outcomes. Nearly half of our planned 40 sites in the US are open to enrol patients and we’ve seen great enthusiasm from participating investigators.”
The trial includes patients with mCRC who have a documented KRAS or NRAS mutation and have previously received one prior chemotherapy regimen with or without bevacizumab in the first line metastatic setting.
Patients are being randomised to onvansertib plus FOLFIRI/bevacizumab versus FOLFIRI/bevacizumab (standard of care).
The primary endpoint is objective response rate determined by the Response Evaluation Criteria in Solid Tumors via an independent central review. The secondary endpoints include progression-free survival, overall survival, duration of response and safety.