Cardiff Oncology Receives “Study May Proceed” from FDA to Initiate Phase 2 Trial

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– Trial will evaluate the safety and efficacy of onvansertib in combination with standard-of-care for second-line treatment of patients with metastatic PDAC who have failed first line treatment with a gemcitabine-based chemotherapy regimen

SAN DIEGO, Jan. 26, 2021 /PRNewswire/ — Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company developing drugs to treat cancers with the greatest medical need for new treatment options, including KRAS-mutated colorectal cancer, castration-resistant prostate cancer and leukemia, today announced that it has received a Study May Proceed letter from the U.S. Food and Drug Administration (FDA) to begin a Phase 2 clinical trial of onvansertib in metastatic pancreatic ductal adenocarcinoma (PDAC).

Cardiff Oncology is a clinical-stage biotechnology company and our mission is to develop new treatment options for cancer patients in indications with the greatest medical need. Our goal is to overcome resistance, improve response to treatment and increase overall survival. Our investigational drug, onvansertib, a first-in-class, third-generation Polo-like Kinase 1 (PLK1) inhibitor, is being evaluated in combination with standard-of-care chemotherapy and targeted therapeutics. We are assessing tumor genomics and using our expertise in biomarker technology to rapidly evaluate patient response to treatment. (PRNewsfoto/Cardiff Oncology, Inc.)
Cardiff Oncology is a clinical-stage biotechnology company and our mission is to develop new treatment options for cancer patients in indications with the greatest medical need. Our goal is to overcome resistance, improve response to treatment and increase overall survival. Our investigational drug, onvansertib, a first-in-class, third-generation Polo-like Kinase 1 (PLK1) inhibitor, is being evaluated in combination with standard-of-care chemotherapy and targeted therapeutics. We are assessing tumor genomics and using our expertise in biomarker technology to rapidly evaluate patient response to treatment. (PRNewsfoto/Cardiff Oncology, Inc.)

This Phase 2 clinical trial is designed to assess the safety and preliminary efficacy of onvansertib in combination with nanoliposomal irinotecan (Onyvide®), 5-FU and leucovorin 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), Emory University, Kansas University Medical Center and Inova Schar Cancer Institute.

“We are excited about the potential of onvansertib in PDAC and originally proposed this trial to Cardiff Oncology because of the results we are seeing in patients treated in our ongoing Phase 1b/2 trial in KRAS-mutated mCRC, which is also evaluating onvansertib in combination with nanoliposomal irinotecan and 5-FU,” said Dr. Daniel H. Ahn, medical oncologist at the Mayo Clinic Cancer Center (Arizona), principal investigator for the Phase 2 PDAC trial and lead investigator for the Phase 1b/2 KRAS-mutated metastatic colorectal cancer (mCRC) trial. “These data show promising response rates with impressive durability across several KRAS variants following treatment. We believe these clinical benefits can be extended to PDAC, as approximately 95% have a KRAS mutation and onvansertib inhibits the proliferation and survival of KRAS-mutated tumor cells. We are looking forward to starting this important trial and providing our PDAC patients with a new second-line therapy with the potential to change the course of this…



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