Cardiff Oncology Selects 30mg Onvansertib Regimen for 2026 Registrational mCRC Study

Company also announces leadership transition as it prepares for late-stage development

Jan. 27, 2026 at 10:47am

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Cardiff Oncology outlined a management transition and provided an updated clinical data readout for its onvansertib drug during a company conference call focused on its ongoing Phase II CRDF-004 trial in first-line RAS-mutated metastatic colorectal cancer (mCRC). The company selected the 30mg dose of onvansertib in combination with FOLFIRI and bevacizumab to advance into a registrational study in 2026, citing dose-dependent benefits across multiple efficacy measures in this treatment arm.

Why it matters

Cardiff Oncology's selection of the 30mg onvansertib regimen for its upcoming registrational study represents a key milestone as the company prepares to move its lead colorectal cancer candidate into late-stage development. The management transition is also aimed at positioning the company optimally for this next phase of growth, as it seeks to build on the promising data generated so far for onvansertib in first-line mCRC.

The details

The CRDF-004 Phase II dose-finding study is evaluating onvansertib, an oral PLK1 inhibitor, in combination with standard first-line mCRC regimens in patients whose tumors harbor RAS mutations. Patients were randomized to receive either 20mg or 30mg of onvansertib alongside FOLFIRI plus bevacizumab or FOLFOX plus bevacizumab, with control patients receiving standard-of-care therapy alone. In an intent-to-treat analysis, Cardiff reported dose-dependent benefits across multiple efficacy measures, most notably in the 30mg onvansertib plus FOLFIRI and bevacizumab cohort, which achieved a confirmed objective response rate of 72.2% compared to 43.2% for the combined standard-of-care regimens.

  • Cardiff expects to provide a more mature CRDF-004 dataset before the end of the first half of 2026, potentially at a medical meeting or similar event.
  • The company anticipates receiving FDA feedback on its registration plan by that time.

The players

Cardiff Oncology

A clinical-stage biopharmaceutical company headquartered in Cambridge, Massachusetts that is dedicated to the discovery, development and commercialization of novel small-molecule therapies designed to modulate the tumor microenvironment and enhance antitumor immune responses.

Mani Mohindru

The interim CEO of Cardiff Oncology, who is also a board member since 2021.

Onvansertib

An oral PLK1 inhibitor that is Cardiff Oncology's lead colorectal cancer candidate.

FOLFIRI

A chemotherapy regimen used in the treatment of colorectal cancer that combines the drugs fluorouracil, leucovorin, and irinotecan.

FOLFOX

A chemotherapy regimen used in the treatment of colorectal cancer that combines the drugs fluorouracil, leucovorin, and oxaliplatin.

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