biostudies-literatureUnknown10(10)Davis EJ<h4>Background</h4>OX40 is a costimulatory receptor upregulated on antigen-activated T cells and constitutively expressed on regulatory T cells (Tregs). INCAGN01949, a fully human immunoglobulin G1κ anti-OX40 agonist monoclonal antibody, was designed to promote tumor-specific immunity by effector T-cell activation and Fcγ receptor-mediated Treg depletion. This first-in-human study was conducted to determine the safety, tolerability, and preliminary efficacy of INCAGN01949.<h4>Methods</h4>Phase I/II, open-label, non-randomized, dose-escalation and dose-expansion study conducted in patients with advanced or metastatic solid tumors. Patients received INCAGN01949 monotherapy (7-1400 mg) in 14-day cycles while deriving benefit. Safety measures, clinical activity, pharmacokinetics, and pharmacodJournal for immunotherapy of cancere004235https://www.ebi.ac.uk/biostudies/studies/S-EPMC9628691biostudies-literatureFirst-in-human phase I/II, open-label study of the anti-OX40 agonist INCAGN01949 in patients with advanced solid tumors.PMC9628691Condamine TClark JJanik JEHari Dass PDavis EJBerthold DBlagden SPCardin DBOrcurto AMehnert JMMiller REKristeleit RCho DCVieito MSpencer KMartin-Liberal JPulini JChen XfalseFirst-in-human phase I/II, open-label study of the anti-OX40 agonist INCAGN01949 in patients with advanced solid tumors.<h4>Background</h4>OX40 is a costimulatory receptor upregulated on antigen-activated T cells and constitutively expressed on regulatory T cells (Tregs). INCAGN01949, a fully human immunoglobulin G1κ anti-OX40 agonist monoclonal antibody, was designed to promote tumor-specific immunity by effector T-cell activation and Fcγ receptor-mediated Treg depletion. This first-in-human study was conducted to determine the safety, tolerability, and preliminary efficacy of INCAGN01949.<h4>Methods</h4>Phase I/II, open-label, non-randomized, dose-escalation and dose-expansion study conducted in patients with advanced or metastatic solid tumors. Patients received INCAGN01949 monotherapy (7-1400 mg) in 14-day cycles while deriving benefit. Safety measures, clinical activity, pharmacokinetics, and pharmacod2022-01-01T00:00:00Z2022 Oct2026-06-08T06:50:03.821Z2026-06-08T03:14:30.525ZS-EPMC96286913631606110.1136/jitc-2021-004235