Cardiff Oncology eyes early-2027 Phase 3 start as colorectal data mature

Cardiff Oncology is lining up a registrational study of onvansertib for first-line RAS-mutated metastatic colorectal cancer. It said on 12 November, alongside third-quarter results, that the trial could start in the first quarter of 2027. The company has not yet disclosed the study's endpoints, size or any regulator feedback, so the scope and cost of the programme are unclear.

The plan rests on a randomised Phase 2 trial. In patients given 30 mg of onvansertib with FOLFIRI and bevacizumab, the point at which half have progressed or died had not yet arrived. In the pooled standard-of-care control arms, that point came at roughly 11 months. Because the onvansertib arm has no median yet, the comparison is incomplete and could shift as follow-up continues.

Cardiff reported cash of $33.8m and expects it to fund operations until the end of the third quarter of 2027. A Phase 3 launch in early 2027 would therefore fall roughly two quarters before that runway ends. The update we reviewed does not describe how the company plans to finance the pivotal study.

The company also said it settled its licensing dispute with Nerviano in September. The update gives no terms, but the settlement removes a point of contention over rights to the asset as Cardiff moves towards a pivotal trial.