Cardiff Oncology doses first patient in colorectal cancer trial

Betsy Goodfellow | March 1, 2024 | News story | Research and Development Cardiff Oncology, Oncology, clinical trial, colorectal cancer 

Cardiff Oncology has announced that it has dosed the first patient in its randomised first-line phase 2 trial, CRDF-004, for patients with RAS-mutated metastatic colorectal cancer (mCRC).

The trial is intended to confirm dosage of onvansertib for use in a subsequent registrational trial, as well as providing safety and efficacy information for the addition of onvansertib to standard-of-care compared to standard-of-care alone.

This trial will include patients with mCRC who have a KRAS or NRAS mutation, and the drug will be added to standard-of-care Folfiri plus bevacizumab or Folfox plus bevacizumab. The primary endpoint will be objective response rate, while secondary endpoints will include progression free survival, duration of response and safety.

Fairooz Kabbinavar MD FACP, chief medical officer of Cardiff Oncology, commented: “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. 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.”

Betsy Goodfellow

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