Cardiff Oncology Announces First Patient Dosed in Randomized First-line RAS-mutated Metastatic Colorectal Cancer Trial (CRDF-004)

2024-03-04

加速审批ASCO会议临床3期临床结果

- Phase 2 trial in patients with RAS-mutated mCRC will evaluate onvansertib plus SoC versus SoC alone in the first-line setting -

- Pfizer Ignite is responsible for the clinical execution of the trial -

- Initial topline results expected in mid-2024 –

- Company will hold a conference call today at 4:30 p.m. ET/1:30 p.m. PT -

Feb. 29, 2024 -- Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company leveraging PLK1 inhibition to develop novel therapies across a range of cancers, today 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.

“Today’s announcement represents an important milestone for Cardiff Oncology and for patients with RAS-mutated mCRC, who have had no new therapies approved in almost 20 years,” said Fairooz Kabbinavar, MD, FACP, Chief Medical Officer of Cardiff Oncology. “Based on the encouraging results from our Phase 1b/2 trial in second-line KRAS-mutated mCRC and our preclinical data demonstrating the powerful impact of combining onvansertib and bevacizumab, we believe the addition of onvansertib in the first-line setting has the potential to provide a meaningful improvement to the efficacy of SoC for mCRC patients with a RAS-mutation. We are especially pleased with the opportunity to leverage Pfizer Ignite’s execution capabilities to advance the development of onvansertib. We strongly believe that we are on the cusp of a transformative advance in the treatment landscape for mCRC.”

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.

“We are pleased that the CRDF-004 trial is underway and look forward to providing clinical development support to advance onvansertib in RAS-mutated mCRC, which we believe has the potential to make an impact in patients with metastatic colorectal cancer,” said Adam Schayowitz, Ph.D., MBA, Head, Product Teams, Portfolio & Program Management at Pfizer Oncology, and member of Cardiff Oncology’s Scientific Advisory Board.

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.

About Cardiff Oncology, Inc.

Cardiff Oncology is a clinical-stage biotechnology company leveraging PLK1 inhibition, a well-validated oncology drug target, to develop novel therapies across a range of cancers. The Company's lead asset is onvansertib, a PLK1 inhibitor being evaluated in combination with standard-of-care (SoC) therapeutics in clinical programs targeting indications such as RAS-mutated metastatic colorectal cancer (mCRC) and metastatic pancreatic ductal adenocarcinoma (mPDAC), as well as in investigator-initiated trials in small cell lung cancer (SCLC) and triple negative breast cancer (TNBC). These programs and the Company's broader development strategy are designed to target tumor vulnerabilities in order to overcome treatment resistance and deliver superior clinical benefit compared to the SoC alone. For more information, please visit https://www.cardiffoncology.com.

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