NEW YORK – Cardiff Oncology said on Tuesday it will begin a Phase II trial of its PLK1 inhibitor onvansertib in patients with metastatic pancreatic ductal adenocarcinoma.
The single-arm trial will evaluate onvansertib in combination with nanoliposomal irinotecan (Ipsen Biopharmaceuticals' Onyvide) and chemotherapy as a second-line treatment for the pancreatic cancer subtype. Cardiff Oncology was cleared to begin the study by the US Food and Drug Administration after it accepted the company's investigational new drug application.
This study was proposed by researchers leading another onvansertib trial in KRAS-mutated colorectal cancer after seeing positive results from that study.
"These data show promising response rates with impressive durability across several KRAS variants following treatment," Daniel Ahn, a medical oncologist at the Mayo Clinic Cancer Center in Arizona, and lead investigator for the studies, said in a statement. "We believe these clinical benefits can be extended to [pancreatic ductal adenocarcinoma], as approximately 95 percent have a KRAS mutation and onvansertib inhibits the proliferation and survival of KRAS-mutated tumor cells."
The pancreatic ductal adenocarcinoma study will enroll about 40 participants at six sites. The primary endpoint is overall response rate. Researchers also will track patients' duration of response, median overall survival, objective response rate after more than two treatment cycles, and disease control rate. Researchers will also assess KRAS allelic burden in circulating tumor DNA using liquid biopsy tests.
San Diego-based Cardiff Oncology, previously known as Trovagene, also is studying onvansertib combinations in other cancers including colorectal cancer, prostate cancer, and acute myeloid leukemia. The company presented early data this month from a Phase Ib study and its expanded access program in KRAS-mutated colorectal cancer where 66 percent of the first nine patients treated with onvansertib experienced tumor shrinkage and responded on average for six months.