biostudies-literatureNaing ACalithera BiosciencesIncyteMerck Sharp and Dohme United Kingdome000249https://www.ebi.ac.uk/biostudies/studies/S-EPMC11235002biostudies-literatureUnknown3(1)<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 timBMJ oncologyFirst-in-human phase 1 study of the arginase inhibitor INCB001158 alone or combined with pembrolizumab in patients with advanced or metastatic solid tumours.PMC11235002N/APapadopoulos KPRahma OKuriakose ESmith MBauer TNaing AKallender HGarralda EPishvaian MJCheng LHanna GJChen XGogov SSaavedra OfalseFirst-in-human phase 1 study of the arginase inhibitor INCB001158 alone or combined with pembrolizumab in patients with advanced or metastatic solid tumours.<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 tim2024-01-01T00:00:00Z20242026-06-06T23:41:25.388Z2026-06-06T03:11:05.751ZS-EPMC112350023988614110.1136/bmjonc-2023-000249