First Patient Dosed in Phase 2 RAS-mutated mCRC Trial by Cardiff Oncology

Cardiff Oncology, a biotechnology firm specializing in PLK1 inhibition for cancer therapy, has commenced a Phase 2 clinical trial for patients with RAS-mutated metastatic colorectal cancer (mCRC). The study, CRDF-004, marks a significant step towards developing new treatment options for this patient group, which has seen a stagnation in therapeutic advancements for nearly two decades.
The trial is being executed by Pfizer Ignite, a comprehensive clinical service provider for biotech entities. It aims to establish the appropriate dosage of onvansertib, Cardiff's lead compound, for a subsequent pivotal trial and to collect data on its safety and effectiveness when combined with the standard-of-care (SoC) treatment, as opposed to SoC alone.
Cardiff's Chief Medical Officer, Dr. Fairooz Kabbinavar, emphasized the importance of this trial for the company and for patients, highlighting the promising outcomes from previous Phase 1b/2 trials and preclinical studies. These studies showed the potential of onvansertib in conjunction with bevacizumab to significantly improve SoC efficacy for mCRC patients with RAS mutations.
The Phase 2 trial will involve 90 participants with documented KRAS or NRAS mutations, who will be randomly assigned to receive either 20mg or 30mg of onvansertib in combination with SoC, or SoC alone. The primary outcome measure is the objective response rate (ORR), with secondary measures including progression-free survival (PFS), response duration, and overall safety.
Pfizer Oncology's Adam Schayowitz, who is also a member of Cardiff's Scientific Advisory Board, expressed enthusiasm for the trial and the potential impact of onvansertib on mCRC treatment. Depending on the CRDF-004 results, Cardiff plans to initiate a Phase 3 trial, CRDF-005, with the intention of registering the drug. The FDA has agreed that an interim ORR could serve as a basis for accelerated approval, with PFS and overall survival trends being considered for full approval.
Cardiff Oncology will host a conference call and webcast to discuss the trial's commencement, providing further insights into the company's strategy and the potential implications of the study's findings for the cancer treatment landscape.

About Cardiff Oncology
Cardiff Oncology is a clinical-stage biotech company that focuses on developing innovative cancer therapies through the inhibition of PLK1, a recognized target in oncology drug development. The company's flagship drug candidate, onvansertib, is currently under evaluation in combination with SoC treatments for various cancer indications, including RAS-mutated mCRC, metastatic pancreatic ductal adenocarcinoma (mPDAC), small cell lung cancer (SCLC), and triple-negative breast cancer (TNBC). Cardiff's approach is designed to target cancer vulnerabilities, aiming to overcome resistance to treatment and offer superior clinical benefits compared to SoC treatments alone.