Pharma Focus Asia

Cardiff Oncology Initiates Randomized Trial for First-Line RAS-Mutated Metastatic Colorectal Cancer Treatment (CRDF-004)

Friday, March 01, 2024

Cardiff Oncology, Inc. (Nasdaq: CRDF), a biotech company specializing in developing new therapies for various cancers using PLK1 inhibition, has announced the dosing of the first patient in its randomized Phase 2 trial, CRDF-004. This trial targets patients with RAS-mutated metastatic colorectal cancer (mCRC). Pfizer Ignite, Pfizer's comprehensive service for biotech firms, is overseeing the clinical execution of this trial. The goal is to determine the appropriate dosage of onvansertib for a subsequent registrational trial and to generate safety and efficacy data by comparing onvansertib plus standard-of-care (SoC) against SoC alone.

Cardiff Oncology, stated, "This marks a significant milestone for Cardiff Oncology and for patients with RAS-mutated mCRC, who have seen no new therapies approved in nearly two decades. Building on the promising outcomes from our Phase 1b/2 trial in second-line KRAS-mutated mCRC and our preclinical evidence showcasing the potent synergy between onvansertib and bevacizumab, we believe that integrating onvansertib into the first-line treatment regimen has the potential to substantially enhance the efficacy of SoC for mCRC patients with RAS mutations. We are particularly pleased to collaborate with Pfizer Ignite to drive forward the development of onvansertib. We strongly believe that we are on the brink of a transformative breakthrough in the treatment landscape for mCRC."

The Phase 2 trial encompasses mCRC patients with documented KRAS or NRAS mutations. Onvansertib will be combined with either SoC FOLFIRI plus bevacizumab or FOLFOX plus bevacizumab. A total of 90 patients will be randomly assigned in a 1:1:1 ratio to receive either 20mg of onvansertib plus SoC, 30mg of onvansertib plus SoC, or SoC alone. The primary endpoint is the objective response rate (ORR), with secondary endpoints including progression-free survival (PFS), duration of response, and safety.

Dr. Adam Schayowitz, Head of Product Teams, Portfolio & Program Management at Pfizer Oncology, and member of Cardiff Oncology’s Scientific Advisory Board, stated, "We are pleased to see the initiation of the CRDF-004 trial and anticipate providing clinical development support to advance onvansertib in RAS-mutated mCRC, a field where we believe it could have a meaningful impact on patients with metastatic colorectal cancer."

Pending the outcomes of CRDF-004, Cardiff Oncology plans to commence a Phase 3 randomized trial, CRDF-005, with the aim of seeking regulatory approval. The FDA has agreed that achieving ORR at an interim stage is an acceptable endpoint for seeking accelerated approval of onvansertib from the CRDF-005 trial, with PFS and the overall survival trend serving as endpoints for full approval.



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