{"database":"biostudies-literature","file_versions":[],"scores":null,"additional":{"omics_type":["Unknown"],"volume":["114(1)"],"submitter":["Iwasa S"],"funding":["Ono Pharmaceutical"],"pubmed_abstract":["EP4, a prostaglandin E<sub>2</sub> receptor, has shown an immunosuppressive activity on cancer cells. This first-in-human study evaluated ONO-4578, a highly selective EP4 antagonist, as monotherapy and in combination with nivolumab in patients with advanced or metastatic solid tumors. A daily dose ranging from 30 mg to 100 mg of ONO-4578 monotherapy and that ranging from 2 mg to 60 mg of ONO-4578 with biweekly nivolumab 240 mg were administered. A total of 31 patients were enrolled, 10 receiving monotherapy and 21 receiving combination therapy. Overall, 26 patients experienced treatment-related adverse events. Dose-limiting toxicities were observed in three patients; one of six patients receiving 100 mg monotherapy developed grade 3 duodenal ulcer and two of six patients receiving 60 mg co"],"journal":["Cancer science"],"pagination":["211-220"],"full_dataset_link":["https://www.ebi.ac.uk/biostudies/studies/S-EPMC9807514"],"repository":["biostudies-literature"],"pubmed_title":["First-in-human study of ONO-4578, an antagonist of prostaglandin E<sub>2</sub> receptor 4, alone and with nivolumab in solid tumors."],"pmcid":["PMC9807514"],"pubmed_authors":["Yamamoto N","Fujiwara Y","Koyama T","Shimizu T","Yoshida T","Shimomura A","Tamura K","Yonemori K","Iida H","Iwasa S","Nishino M","Kondo S","Yokoyama F","Kondo M","Sudo K","Kitano S","Sato J"],"additional_accession":[]},"is_claimable":false,"name":"First-in-human study of ONO-4578, an antagonist of prostaglandin E<sub>2</sub> receptor 4, alone and with nivolumab in solid tumors.","description":"EP4, a prostaglandin E<sub>2</sub> receptor, has shown an immunosuppressive activity on cancer cells. This first-in-human study evaluated ONO-4578, a highly selective EP4 antagonist, as monotherapy and in combination with nivolumab in patients with advanced or metastatic solid tumors. A daily dose ranging from 30 mg to 100 mg of ONO-4578 monotherapy and that ranging from 2 mg to 60 mg of ONO-4578 with biweekly nivolumab 240 mg were administered. A total of 31 patients were enrolled, 10 receiving monotherapy and 21 receiving combination therapy. Overall, 26 patients experienced treatment-related adverse events. Dose-limiting toxicities were observed in three patients; one of six patients receiving 100 mg monotherapy developed grade 3 duodenal ulcer and two of six patients receiving 60 mg co","dates":{"release":"2023-01-01T00:00:00Z","publication":"2023 Jan","modification":"2026-05-27T21:05:02.175Z","creation":"2024-11-14T18:56:41.013Z"},"accession":"S-EPMC9807514","cross_references":{"pubmed":["36082616"],"doi":["10.1111/cas.15574"]}}