biostudies-literatureMeric-Bernstam FCenter for Clinical and Translational Sciences, University of Texas Health Science Center at Houston (CCTS, UTHealth)NCATS NIH HHSNCI NIH HHSUniversity of Texas MD Anderson Cancer CenterCenter for Clinical and Translational Sciences, University of Texas Health Science Center at Houston110-121https://www.ebi.ac.uk/biostudies/studies/S-EPMC11188043biostudies-literatureUnknown29(1)<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.Clinical cancer research : an official journal of the American Association for Cancer ResearchCombination 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.PMC11188043P30 CA047904P30 CA016672UL1 TR003167NCATS Grant UL1 TR0003167Sandhu SMeric-Bernstam FKattenhorn LShimizu TLewis NDummer RNair NHamid OMuller TBhatia SBean ALuke JJMcWhirter SMPelletier MLong GVStradella ASweis RFKasper SSpreafico AChen XSteeghs NfalseCombination 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.<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.2023-01-01T00:00:00Z2023 Jan2026-05-29T12:34:30.389Z2025-04-20T02:12:51.069ZS-EPMC111880433628287410.1158/1078-0432.CCR-22-223510.1158/1078-0432.ccr-22-2235