Cardiff Oncology, Inc. announced on April 15, 2025, the successful completion of patient enrollment in its ongoing Phase 2 CRDF-004 trial. This trial is evaluating onvansertib in combination with standard of care (SoC) for the treatment of first-line RAS-mutated metastatic colorectal cancer (mCRC). The achievement of full enrollment represents a crucial operational milestone for the company.
The CRDF-004 trial enrolled patients with documented KRAS or NRAS mutations and unresectable disease across 41 clinical sites in the United States. Patients were randomized to receive either 20mg of onvansertib plus SoC, 30mg of onvansertib plus SoC, or SoC alone. The primary endpoint of the trial is objective response rate (ORR), with secondary endpoints including progression-free survival (PFS), duration of response (DOR), and safety.
The company had previously released initial results from the CRDF-004 trial in December 2024, which showed promising efficacy signals. Cardiff Oncology anticipates reporting additional clinical data from the CRDF-004 trial in the first half of 2025. This completion of enrollment positions the company to advance towards regulatory discussions with the FDA.
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