Clinical Trial: NCT03829410 - My Cancer Genome A phase Ib/II study of onvansertib (PCM-075) in ... Cardiff Oncology onvansertib gets FDA fast track ... Patients must also have . The U.S. Food and Drug Administration (FDA) granted Fast Track Designation to onvansertib, an orally administered highly - selective Polo-like Kinase 1 (PLK1) inhibitor that is being developed in patients with KRAS-mutated metastatic colorectal cancer (mCRC). Onvansertib is an oral, highly selective PLK1 inhibitor that demonstrates single agent and synergistic activity with irinotecan and 5-FU in preclinical CRC models. Onvansertib Promising in Colon Cancer with KRAS Mutation. Cardiff Oncology Data Continues to Demonstrate Efficacy of ... Exhibit 99.1 . The Polo-like kinase 1 inhibitor onvansertib represents a ... Daniel H. Ahn, DO Cardiff Oncology Data Continues to Demonstrate Efficacy of ... FOLFIRI (with or without 5FU bolus and continuous infusion)/bevacizumab plus onvansertib is appropriate for the participant as determined by the treating physician, including participants who have previously been treated with FOLFIRI Histologically confirmed metastatic and unresectable CRC with a confirmed KRAS mutation Age ≥ 18 years Data Demonstrate the Clinical Benefit of Onvansertib in ... 1 AACR: Early Trovagene data offer hope for KRAS-mutant ... A phase 1b/2 trial of the PLK1 inhibitor onvansertib in combination with FOLFIRI-bev in 2L treatment of KRAS-mutated (mKRAS) metastatic colorectal carcinoma (mCRC) Abstract Number: 100 Cardiff Oncology to Host Key Opinion Leader Webinar on Onvansertib for the Treatment of KRAS-Mutated Metastatic Colorectal Cancer PRESS RELEASE PR Newswire Apr. Global Colorectal Cancer Disease Insights and Market Forecasts Report 2020-2026: Key Therapies Include Avastin, Erbitux, Keytruda, Vectibix, Lonsurf & Onvansertib - ResearchAndMarkets.com Posted . The regimen of onvansertib, FOLFIRI (5-fluorouracil, leucovorin, irinotecan), and bevacizumab (Avastin) showed early activity without any notable safety signals in patients with KRAS -mutated. About the Phase 1b/2 Trial of Onvansertib in Metastatic KRAS-mutated Colorectal Cancer Cardiff Oncology's ongoing KRAS-mutated metastatic colorectal cancer clinical trial is a single-arm Phase 1b . Data from an ongoing Phase Ib/II clinical trial of onvansertib, also known as NMS-1286937 and PCM-075, in combination with FOLFIRI* and bevacizumab (Avastin®; Genentech/Roche) for second-line treatment of KRAS-mutated metastatic colorectal cancer (mCRC) were featured in a poster presentation at the American Society of Clinical Oncology Gastrointestinal Cancers Symposium (ASCO-GI) in San . Additionally, KRAS mutated vs wild-type tumor cells showed higher sensitivity to onvansertib. We are developing onvansertib, a first-in-class, third-generation Polo-like Kinase 1 (PLK1) inhibitor, in combination with standard-of-care chemotherapy and targeted therapeutics. 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. Myth. Other tests, such as an at-home stool test or a virtual colonoscopy can be used to screen for colon cancer. [RIPS] Fact. The trial, A Phase 1b /2 Study of Onvansertib (PCM-075) in Combination with FOLFIRI and Bevacizumab for Second-Line Treatment of Metastatic Colorectal Cancer in Patients with a KRAS Mutation, will enroll up to 44 patients with a KRAS mutation and histologically confirmed metastatic and unresectable disease. This study examines the feasibility of using G207 in the treatment of human colorectal cancer and defines the biological determinants of its antitumor efficacy. In the Phase, 1b/2 study the company has checked the safety and preliminary efficacy of onvansertib in combination with FOLFIRI and bevacizumab in second-line KRAS-mutated metastatic colorectal cancer. The investigational KRAS G12C inhibitor drug Adagrasib (MRTX849) yielded clinical responses in patients with non-small cell lung cancer (NSCLC) and colorectal cancer, and other solid tumors harboring KRAS G12C mutations, according the results of a from the phase I - II Krystal clinical trials. The combination of onvansertib plus with 5-fluorouracil, FOLFIRI, and bevacizumab was shown to have preliminary efficacy with acceptable safety when used as a second-line treatment for patients. The combination of Onvansertib with the current standard of care - FOLFIRI and Avastin - was found to have preliminary efficacy and favorable side effects when used as a second-line treatment for patients with KRAS-mutated metastatic colorectal cancer. The firm, formerly named Trovagene, is also evaluating the agent combined with chemotherapy for KRAS-mutated metastatic colorectal cancer. Onvansertib, a Plk1-specific ATP competitive inhibitor, blocks the phosphorylation of Plk1 substrates 16. The U.S. Food and Drug Administration reviewed the Company's request for Fast Track designation and concluded that investigation of onvansertib, in combination with FOLFIRI/bevacizumab, for second-line treatment of patients with KRAS-mutated metastatic colorectal cancer meets the criteria for a Fast Track development program In addition, patients must have . 9/2021. Onvansertib is currently tested in solid metastatic cancers. The FDA has granted Fast Track designation to onvansertib (PCM-075) for the second-line treatment of patients with KRAS -mutated metastatic colorectal cancer (mCRC), according to Cardiff Oncology, Inc., the manufacturer of the oral PLK1 inhibitor. Trovagene believes the combination of onvansertib with other compounds has the potential to improve clinical efficacy in acute myeloid leukemia (AML), metastatic castration-resistant prostate cancer (mCRPC), non-Hodgkin lymphoma (NHL), colorectal cancer and triple-negative breast cancer (TNBC), as well as other types of cancer. Up to . Cardiff Oncology Data Continues to Demonstrate Efficacy of Onvansertib in Patients with KRAS-Mutated Metastatic Colorectal Cancer Presented at ASCO - Positive data presented at ASCO follows . Cardiff Oncology believes the combination of onvansertib with other compounds has the potential to improve clinical efficacy in acute myeloid leukemia (AML), metastatic castration-resistant prostate cancer (mCRPC), non-Hodgkin lymphoma (NHL), colorectal cancer and triple-negative breast cancer (TNBC), as well as other types of cancer. Additionally, KRAS mutated versus wild-type cells showed higher sensitivity to onvansertib. Onvansertib, an oral and highly-selective Polo-like Kinase 1 (PLK1) inhibitor, has shown strong antitumor activity in preclinical models of colorectal cancers, and demonstrated significant and durable synergistic antitumor activity in combination with irinotecan, and was greater than either drug alone. Onvansertib (Trovagene) in combination with the standard-of-care (SOC) leucovorin, fluorouracil, and irinotecan (FOLFIRI) or bevacizumab (Avastin) demonstrated an improved objective response rate (ORR) and progression-free survival (PFS) in the second-line treatment of KRAS-mutated metastatic colorectal cancer (mCRC), according to results from a phase 1b/2 trial (NCT03829410). Onvansertib Triplet Shows Promise in KRAS-Mutant Metastatic Colorectal Cancer February 4, 2020 Nichole Tucker In an interview with Targeted Oncology, Daniel H. Ahn, DO, discussed the phase Ib/II study of onvansertib plus FOLFIRI and bevacizumab for the treatment of patients with metastatic colorectal cancer with a KRAS mutation. Onvansertib for KRAS mutant colorectal cancer A study suggests a new medicine for KRAS mutant colorectal cancer. Onvansertib is the only PLK1 inhibitor and targeted therapy in clinical development that has demonstrated activity against aggressive and difficult-to-drug KRAS mutations in metastatic colorectal cancer. This v … Our clinical development programs incorporate tumor genomics and biomarker technology to refine assessment of patient response to treatment. G207 is a multi-mutated, replication-competent type-1 herpes simplex virus designed to target, infect, and lyse neurological tumors. Cardiff Oncology is running a clinical program assessing onvansertib — in combination with standard-of-care (SOC) FOLFIRI/bevacizumab — as a second-line treatment for patients suffering from KRAS-mutated metastatic colorectal cancer. San Diego, 29.05.2020 We are delighted to learn the most recent updates from Onvansertib (licensed from Nerviano Medical Sciences) : Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage oncology therapeutics company developing drugs to treat cancers with the greatest medical need for new treatment options, including KRAS-mutated colorectal cancer, Zytiga®-resistant prostate cancer and . It has been updated and shared here with permission from OncLive. KRAS mutations affect a large patient population and remained difficult to treat in the past because they resist EGFR antibodies. 1,3,4 RAS is an oncogene —a gene that encodes proteins that . The ongoing trial, A Phase 1b/2 Study of Onvansertib (PCM-075) in Combination with FOLFIRI and Bevacizumab for Second?Line Treatment of Metastatic Colorectal Cancer in Patients with a KRAS Mutation (NCT03829410) is evaluating the safety and efficacy of onvansertib in combination with standard-of-care FOLFIRI and Avastin® (bevacizumab). Onvansertib is an oral, highly selective PLK1 inhibitor that demonstrates single agent and synergistic activity with irinotecan in preclinical CRC models. 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). Onvansertib for KRAS mutant colorectal cancer A study suggests a new medicine for KRAS mutant colorectal cancer. 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