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Cardiff Oncology Begins Phase II Onvansertib Trial in KRAS-, NRAS-Mutant Colorectal Cancer

NEW YORK – Cardiff Oncology on Tuesday began treating patients in the Phase II ONSEMBLE trial of its PLK1 inhibitor onvansertib in KRAS- or NRAS-mutated metastatic colorectal cancer.

Cardiff is evaluating the combination of onvansertib plus the standard-of-care treatment of chemotherapy and Genentech's Avastin (bevacizumab) versus the standard-of-care regimen alone. Researchers will enroll up to 150 patients with KRAS- or NRAS-mutant colorectal cancer who have progressed on one prior line of chemo in the metastatic setting.

Participants will be enrolled to receive either 20 mg or 30 mg of onvansertib plus standard of care or into the control arm. The trial's primary endpoint is overall response rate.

"[Metastatic colorectal cancer] is a difficult-to-treat cancer and patients in the second-line setting need novel therapeutic options to improve clinical outcomes," Fairooz Kabbinavar, chief medical officer of Cardiff Oncology, said in a statement. "Based on our open-label Phase Ib/II trial, we believe the combination of onvansertib with FOLFIRI/bevacizumab could positively impact patients' responses to treatment and the durability of the responses."

San Diego-based Cardiff reported data from the earlier trial of onvansertib in this patient population last year. That data showed a 34 percent response rate, a 92 percent disease control rate, and a median progression-free survival of 9.4 months.

Cardiff is also exploring onvansertib combinations in pancreatic cancer in a Phase II trial and in preclinical studies in ovarian cancer.