Cardiff Oncology, Inc. announced that the first patient was dosed in its randomized first-line Phase 2 trial, CRDF-004, for patients with RAS-mutated metastatic colorectal cancer (mCRC). The trial, whose clinical execution is being conducted by Pfizer Ignite, Pfizer?s new end-to-end service for biotech companies, is designed to confirm the dose of onvansertib for a subsequent registrational trial, and generate safety and efficacy data for onvansertib when added to standard-of-care (SoC) vs. SoC alone.

The Phase 2 trial includes patients with mCRC who have a documented KRAS or NRAS mutation. Onvansertib will be added to SoC FOLFIRI plus bevacizumab or FOLFOX plus bevacizumab. A total of 90 patients will be randomized in a 1:1:1 ratio to either 20mg of onvansertib plus SoC, 30mg of onvansertib plus SoC, or SoC alone.

The primary endpoint is objective response rate (ORR), and the secondary endpoints include progression-free survival (PFS), duration of response and safety. Contingent upon the results of CRDF-004, Cardiff Oncology will initiate a Phase 3, randomized trial, CRDF-005, with registrational intent. The FDA has agreed that ORR at an interim point is an acceptable endpoint to pursue accelerated approval of onvansertib from the CRDF-005 trial, with PFS and trend in overall survival being the endpoints for full approval.