Cardiff Oncology has completed patient enrollment in its Phase 2 CRDF-004 trial. The trial is evaluating onvansertib combined with standard care for first-line treatment of RAS-mutated metastatic colorectal cancer (mCRC). Initial results were released in December 2024, with more data expected in the first half of 2025.
This trial completion is potentially important for mCRC patients, who haven’t seen substantial treatment advances in decades. If successful, onvansertib could offer a new therapeutic option for this patient population, potentially improving response rates and survival outcomes. The positive enrollment underscores the interest in this potential new treatment approach within the oncology community.
The CRDF-004 trial enrolled patients with KRAS or NRAS mutations and unresectable disease across 41 U.S. sites. Patients were randomized to receive either 20mg or 30mg of onvansertib plus standard of care (FOLFIRI plus bevacizumab or FOLFOX plus bevacizumab), or standard of care alone. The primary endpoint is objective response rate (ORR), with secondary endpoints including progression-free survival (PFS), duration of response (DOR), and safety.
The anticipated data release in the first half of 2025 will be critical. Positive results could lead to regulatory discussions with the FDA and potentially accelerate onvansertib’s path to market, offering a new treatment option for patients with this challenging cancer. Further, positive results may spur additional research into onvansertib’s potential in other cancers.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
