On June 8, 2021 Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company developing onvansertib to treat cancers with the greatest medical needs for new treatment options, including KRAS-mutated colorectal cancer, pancreatic cancer and castrate-resistant prostate cancer, reported that the first patient has been dosed in its Phase 2 clinical trial of onvansertib in combination with nanoliposomal irinotecan and 5-FU as a second-line treatment for metastatic pancreatic ductal adenocarcinoma (PDAC) (Press release, Cardiff Oncology, JUN 8, 2021, View Source [SID1234583702]).
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The Phase 2 open-label, multicenter trial, which is an integral part of Cardiff Oncology’s focus on KRAS-mutated solid tumor cancers, is designed to assess the safety and preliminary efficacy of onvansertib in combination with standard-of-care as a second-line treatment in patients with metastatic PDAC who have failed first-line gemcitabine-based therapy. The trial is expected to enroll approximately 40 patients across six sites in the U.S., including the three Mayo Clinic Cancer Centers (Arizona, Minnesota and Florida), Kansas University Medical Center, The University of Nebraska Medical Center and Inova Schar Cancer Institute.
"We believe that adding onvansertib to standard-of-care therapy may improve the current dim prognosis for PDAC patients where currently second-line treatment confers only a 7.7% response rate and 3.1-month median progression-free survival," said Daniel H. Ahn, D.O., principal investigator for the trial and medical oncologist, Mayo Clinic Cancer Center, Arizona. "There is increasing evidence in the ongoing Phase 2 trial in KRAS-mutated mCRC that the synergistic effect of onvansertib in combination with irinotecan and 5-FU is resulting in meaningful clinical benefit and improving outcomes for patients with KRAS-mutated cancers and we are optimistic that we will see similar results in this PDAC trial."
Dr. Mark Erlander, chief executive officer of Cardiff Oncology added, "Onvansertib’s inhibitory effect on the proliferation and survival of KRAS-mutated tumor cells has, notably, shown synergistic clinical benefit in combination with irinotecan and 5-FU in our KRAS-mutated metastatic colorectal cancer trial (mCRC). As metastatic PDAC tumors bear KRAS mutations about 95% of the time, we see an opportunity for onvansertib to improve response rates and increase progression-free survival in this indication with such marked unmet need. The dosing of the first patient in our Phase 2 PDAC trial represents an important step in pursuit of this opportunity, and we look forward to its continued progress."
About the Phase 2 Trial of Onvansertib in Metastatic PDAC
This trial is an open-label, multi-center study designed to assess the safety and efficacy of onvansertib in combination with nanoliposomal irinotecan (Onyvide), leucovorin, and 5-FU as
a second-line treatment in patients with metastatic PDAC. The trial is expected to enroll approximately 40 patients with histologically confirmed measurable and metastatic PDAC who have failed treatment with one prior line of gemcitabine-based chemotherapy. Patients will receive nanoliposomal irinotecan, leucovorin, and 5-FU on Day 1 of 14-day cycles in combination with onvansertib 12 mg/m2 on Days 1-10, or 15 mg/m2, on Days 1-5 of each 14-day cycle. The study will be conducted at six clinical trial sites across the U.S: Mayo Clinic (Arizona, Minnesota, Florida), Kansas University Medical Center, The University of Nebraska Medical Center and Inova Schar Cancer Institute. The primary endpoint will be objective response rate (ORR) by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1). Key secondary and exploratory endpoints include duration of response, median overall survival, ORR in patients receiving more than two treatment cycles, disease control rate (defined as complete response, partial response or stable disease by RECIST v1.1 over the entire treatment period), and assessment of KRAS allelic burden in liquid biopsies as measured by circulating tumor DNA (ctDNA). Please refer to clinicaltrials.gov NCT04752696 for additional clinical trial information.