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Cardiff Oncology Doses First Patient in Phase II Onvansertib Trial in Pancreatic Cancer

NEW YORK – Cardiff Oncology said on Tuesday that it has dosed the first metastatic pancreatic cancer patient with its PLK1 inhibitor onvansertib and standard-of-care chemotherapy in a Phase II trial.

In the 40-patient, US-based trial, Cardiff will evaluate the safety and efficacy of onvansertib combined with an irinotecan/5-FU chemotherapy regimen as second-line treatment for patients with metastatic pancreatic ductal adenocarcinoma.

The study's primary endpoint is overall response rate, but investigators are also interested in measuring duration of response, overall survival, and decrease in KRAS allelic burden in patients' circulating tumor DNA, as assessed with liquid biopsies.

The interest in measuring KRAS allelic burden among patients treated with the onvansertib combination is in line with Cardiff's ongoing focus on treating patients with KRAS-mutated solid tumors. The firm, formerly named Trovagene, is also evaluating the agent combined with chemotherapy for KRAS-mutated metastatic colorectal cancer.

According to a statement from Cardiff CEO Mark Erlander, onvansertib combined with irinotecan and 5-FU have shown synergistic anti-tumor activity against KRAS-mutated cells in that colorectal cancer trial. As of an April data readout, 39 percent of evaluable colorectal cancer patients had achieved a partial response to the onvansertib-chemotherapy combination, and the median progression-free survival was 9.4 months.

Because roughly 95 percent of metastatic pancreatic ductal adenocarcinoma tumors harbor KRAS mutations, Erlander said, "we see an opportunity for onvansertib to improve response rates and increase progression-free survival in this indication with such marked unmet need."