{"database":"biostudies-literature","file_versions":[],"scores":null,"additional":{"submitter":["Meric-Bernstam F"],"funding":["Center for Clinical and Translational Sciences, University of Texas Health Science Center at Houston (CCTS, UTHealth)","NCATS NIH HHS","NCI NIH HHS","University of Texas MD Anderson Cancer Center","Center for Clinical and Translational Sciences, University of Texas Health Science Center at Houston"],"pagination":["110-121"],"full_dataset_link":["https://www.ebi.ac.uk/biostudies/studies/S-EPMC11188043"],"repository":["biostudies-literature"],"omics_type":["Unknown"],"volume":["29(1)"],"pubmed_abstract":["<h4>Purpose</h4>The stimulator of IFN genes (STING) is a transmembrane protein that plays a role in the immune response to tumors. Single-agent STING agonist MIW815 (ADU-S100) has demonstrated immune activation but limited antitumor activity. This phase Ib, multicenter, dose-escalation study assessed the safety and tolerability of MIW815 plus spartalizumab (PDR001), a humanized IgG4 antibody against PD-1, in 106 patients with advanced solid tumors or lymphomas.<h4>Patients and methods</h4>Patients were treated with weekly intratumoral injections of MIW815 (50-3,200 μg) on a 3-weeks-on/1-week-off schedule or once every 4 weeks, plus a fixed dose of spartalizumab (400 mg) intravenously every 4 weeks.<h4>Results</h4>Common adverse events were pyrexia (n = 23; 22%), injection site pain (n = 21; 20%), and diarrhea (n = 12; 11%). Overall response rate was 10.4%. The MTD was not reached. Pharmacodynamic biomarker analysis demonstrated on-target activity.<h4>Conclusions</h4>The combination of MIW815 and spartalizumab was well tolerated in patients with advanced/metastatic cancers, including in patients with anti-PD-1 refractory disease. Minimal antitumor responses were seen."],"journal":["Clinical cancer research : an official journal of the American Association for Cancer Research"],"pubmed_title":["Combination of the STING Agonist MIW815 (ADU-S100) and PD-1 Inhibitor Spartalizumab in Advanced/Metastatic Solid Tumors or Lymphomas: An Open-Label, Multicenter, Phase Ib Study."],"pmcid":["PMC11188043"],"funding_grant_id":["P30 CA047904","P30 CA016672","UL1 TR003167","NCATS Grant UL1 TR0003167"],"pubmed_authors":["Sandhu S","Meric-Bernstam F","Kattenhorn L","Shimizu T","Lewis N","Dummer R","Nair N","Hamid O","Muller T","Bhatia S","Bean A","Luke JJ","McWhirter SM","Pelletier M","Long GV","Stradella A","Sweis RF","Kasper S","Spreafico A","Chen X","Steeghs N"],"additional_accession":[]},"is_claimable":false,"name":"Combination of the STING Agonist MIW815 (ADU-S100) and PD-1 Inhibitor Spartalizumab in Advanced/Metastatic Solid Tumors or Lymphomas: An Open-Label, Multicenter, Phase Ib Study.","description":"<h4>Purpose</h4>The stimulator of IFN genes (STING) is a transmembrane protein that plays a role in the immune response to tumors. Single-agent STING agonist MIW815 (ADU-S100) has demonstrated immune activation but limited antitumor activity. This phase Ib, multicenter, dose-escalation study assessed the safety and tolerability of MIW815 plus spartalizumab (PDR001), a humanized IgG4 antibody against PD-1, in 106 patients with advanced solid tumors or lymphomas.<h4>Patients and methods</h4>Patients were treated with weekly intratumoral injections of MIW815 (50-3,200 μg) on a 3-weeks-on/1-week-off schedule or once every 4 weeks, plus a fixed dose of spartalizumab (400 mg) intravenously every 4 weeks.<h4>Results</h4>Common adverse events were pyrexia (n = 23; 22%), injection site pain (n = 21; 20%), and diarrhea (n = 12; 11%). Overall response rate was 10.4%. The MTD was not reached. Pharmacodynamic biomarker analysis demonstrated on-target activity.<h4>Conclusions</h4>The combination of MIW815 and spartalizumab was well tolerated in patients with advanced/metastatic cancers, including in patients with anti-PD-1 refractory disease. Minimal antitumor responses were seen.","dates":{"release":"2023-01-01T00:00:00Z","publication":"2023 Jan","modification":"2026-05-29T12:34:30.389Z","creation":"2025-04-20T02:12:51.069Z"},"accession":"S-EPMC11188043","cross_references":{"pubmed":["36282874"],"doi":["10.1158/1078-0432.CCR-22-2235","10.1158/1078-0432.ccr-22-2235"]}}