{"database":"biostudies-literature","file_versions":[],"scores":null,"additional":{"submitter":["Naing A"],"funding":["Calithera Biosciences","Incyte","Merck Sharp and Dohme United Kingdom"],"pagination":["e000249"],"full_dataset_link":["https://www.ebi.ac.uk/biostudies/studies/S-EPMC11235002"],"repository":["biostudies-literature"],"omics_type":["Unknown"],"volume":["3(1)"],"pubmed_abstract":["<h4>Objective</h4>The arginase inhibitor INCB001158 was evaluated for safety (primary endpoint) in locally advanced or metastatic solid tumours; pharmacokinetics, pharmacodynamics and efficacy were also assessed.<h4>Methods and analysis</h4>In this non-randomised, open-label, three-part phase 1 study, INCB001158 was orally administered two times per day as monotherapy or in combination with intravenous pembrolizumab 200 mg every 3 weeks. Dose expansion was conducted in tumour-type cohorts (with or without prior anti-PD-1/PD-L1 (programmed death protein 1/programmed death ligand 1) therapy).<h4>Results</h4>A total of 107 patients received INCB001158 50-150 mg two times per day as monotherapy, and 153 patients, including 6 with moderate renal impairment, received INCB001158 50-100 mg two tim"],"journal":["BMJ oncology"],"pubmed_title":["First-in-human phase 1 study of the arginase inhibitor INCB001158 alone or combined with pembrolizumab in patients with advanced or metastatic solid tumours."],"pmcid":["PMC11235002"],"funding_grant_id":["N/A"],"pubmed_authors":["Papadopoulos KP","Rahma O","Kuriakose E","Smith M","Bauer T","Naing A","Kallender H","Garralda E","Pishvaian MJ","Cheng L","Hanna GJ","Chen X","Gogov S","Saavedra O"],"additional_accession":[]},"is_claimable":false,"name":"First-in-human phase 1 study of the arginase inhibitor INCB001158 alone or combined with pembrolizumab in patients with advanced or metastatic solid tumours.","description":"<h4>Objective</h4>The arginase inhibitor INCB001158 was evaluated for safety (primary endpoint) in locally advanced or metastatic solid tumours; pharmacokinetics, pharmacodynamics and efficacy were also assessed.<h4>Methods and analysis</h4>In this non-randomised, open-label, three-part phase 1 study, INCB001158 was orally administered two times per day as monotherapy or in combination with intravenous pembrolizumab 200 mg every 3 weeks. Dose expansion was conducted in tumour-type cohorts (with or without prior anti-PD-1/PD-L1 (programmed death protein 1/programmed death ligand 1) therapy).<h4>Results</h4>A total of 107 patients received INCB001158 50-150 mg two times per day as monotherapy, and 153 patients, including 6 with moderate renal impairment, received INCB001158 50-100 mg two tim","dates":{"release":"2024-01-01T00:00:00Z","publication":"2024","modification":"2026-06-06T23:41:25.388Z","creation":"2026-06-06T03:11:05.751Z"},"accession":"S-EPMC11235002","cross_references":{"pubmed":["39886141"],"doi":["10.1136/bmjonc-2023-000249"]}}