biostudies-literatureKim TWNCATS NIH HHSNCI NIH HHS3452-3463https://www.ebi.ac.uk/biostudies/studies/S-EPMC9662912biostudies-literatureUnknown28(16)<h4>Purpose</h4>OX40, a receptor transiently expressed by T cells upon antigen recognition, is associated with costimulation of effector T cells and impairment of regulatory T-cell function. This first-in-human study evaluated MOXR0916, a humanized effector-competent agonist IgG1 monoclonal anti-OX40 antibody.<h4>Patients and methods</h4>Eligible patients with locally advanced or metastatic refractory solid tumors were treated with MOXR0916 intravenously once every 3 weeks (Q3W). A 3+3 dose-escalation stage (0.2-1,200 mg; n = 34) was followed by expansion cohorts at 300 mg (n = 138) for patients with melanoma, renal cell carcinoma, non-small cell lung carcinoma, urothelial carcinoma, and triple-negative breast cancer.<h4>Results</h4>MOXR0916 was well tolerated with no dose-limiting toxicitClinical cancer research : an official journal of the American Association for Cancer ResearchFirst-In-Human Phase I Study of the OX40 Agonist MOXR0916 in Patients with Advanced Solid Tumors.PMC9662912P30 CA008748UL1 TR001863Gordon MBurris HABang YJSznol MMiller WHStefanich ERhee IKim JChow LQPishvaian MJHodi FSLesokhin AMSiu LLKim TWAwada ARishipathak DMcArthur GAde Miguel Luken MJHuseni MCervantes ARutten AAnderson MCamidge DRChen SCPourmohamad TfalseFirst-In-Human Phase I Study of the OX40 Agonist MOXR0916 in Patients with Advanced Solid Tumors.<h4>Purpose</h4>OX40, a receptor transiently expressed by T cells upon antigen recognition, is associated with costimulation of effector T cells and impairment of regulatory T-cell function. This first-in-human study evaluated MOXR0916, a humanized effector-competent agonist IgG1 monoclonal anti-OX40 antibody.<h4>Patients and methods</h4>Eligible patients with locally advanced or metastatic refractory solid tumors were treated with MOXR0916 intravenously once every 3 weeks (Q3W). A 3+3 dose-escalation stage (0.2-1,200 mg; n = 34) was followed by expansion cohorts at 300 mg (n = 138) for patients with melanoma, renal cell carcinoma, non-small cell lung carcinoma, urothelial carcinoma, and triple-negative breast cancer.<h4>Results</h4>MOXR0916 was well tolerated with no dose-limiting toxicit2022-01-01T00:00:00Z2022 Aug2026-07-14T21:05:27.443Z2025-04-04T20:22:01.696ZS-EPMC96629123569959910.1158/1078-0432.CCR-21-4020