Cardiff Oncology Completes Patient Enrollment In Ongoing Phase 2 CRDF-004 Trial Evaluating Onvansertib In Combination With SoC For Treatment Of First-line RAS-mutated mCRC

- Initial results from randomized Phase 2 CRDF-004 trial in RAS-mut mCRC were released in December 2024 -

- Additional clinical data from CRDF-004 trial expected in 1H 2025 -

SAN DIEGO, April 15, 2025 (GLOBE NEWSWIRE) -- Cardiff Oncology, Inc. (NASDAQ:CRDF), a clinical-stage biotechnology company leveraging PLK1 inhibition to develop novel therapies across a range of cancers, today announced completion of patient enrollment in the ongoing Phase 2 CRDF-004 trial evaluating onvansertib in combination with standard of care (SoC) for the treatment of first-line RAS-mutated metastatic colorectal cancer (mCRC).

"The successful completion of enrollment in our first-line trial for patients with RAS mutant mCRC represents an important milestone in our mission to develop new treatments for a population who have not seen meaningful treatment advancements for decades. We are deeply grateful for our patients, care-givers and clinical investigators, whose commitment to the trial has been integral in this achievement," said Mark Erlander, Chief Executive Officer of Cardiff Oncology. "As we move forward, we are eager to continue accruing additional clinical data and advancing towards regulatory discussions with FDA with the goal of bringing this transformative therapy to patients."

The Phase 2 CRDF-004 trial has reached our targeted enrollment of patients with first-line mCRC across 41 clinical sites in the U.S. Patients in the trial have a documented KRAS or NRAS mutation with unresectable disease. Onvansertib is added to SoC consisting of FOLFIRI plus bevacizumab or FOLFOX plus bevacizumab. Patients are randomized 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 (DOR) and safety.

The company anticipates reporting additional clinical data from the CRDF-004 trial in the first half of 2025.