biostudies-literatureDiab APfizer71-83https://www.ebi.ac.uk/biostudies/studies/S-EPMC9401502biostudies-literatureUnknown28(1)<h4>Purpose</h4>Stimulation of effector T cells is an appealing immunotherapeutic approach in oncology. OX40 (CD134) is a costimulatory receptor expressed on activated CD4⁺ and CD8⁺ T cells. Induction of OX40 following antigen recognition results in enhanced T-cell activation, proliferation, and survival, and OX40 targeting shows therapeutic efficacy in preclinical studies. We report the monotherapy dose-escalation portion of a multicenter, phase I trial (NCT02315066) of ivuxolimab (PF-04518600), a fully human immunoglobulin G2 agonistic monoclonal antibody specific for human OX40.<h4>Patients and methods</h4>Adult patients (<i>N</i> = 52) with selected locally advanced or metastatic cancers received ivuxolimab 0.01 to 10 mg/kg. Primary endpoints were safety and tolerClinical cancer research : an official journal of the American Association for Cancer ResearchA Phase I, Open-Label, Dose-Escalation Study of the OX40 Agonist Ivuxolimab in Patients with Locally Advanced or Metastatic Cancers.PMC9401502NCT02315066Doi THamid OKlempner SJSalek-Ardakani SEskens FALMGanguly BThompson JAJoh TLiao KChou JDiab AFleener CEl-Khoueiry ABRos WTaylor CTWang XHu-Lieskovan SfalseA Phase I, Open-Label, Dose-Escalation Study of the OX40 Agonist Ivuxolimab in Patients with Locally Advanced or Metastatic Cancers.<h4>Purpose</h4>Stimulation of effector T cells is an appealing immunotherapeutic approach in oncology. OX40 (CD134) is a costimulatory receptor expressed on activated CD4⁺ and CD8⁺ T cells. Induction of OX40 following antigen recognition results in enhanced T-cell activation, proliferation, and survival, and OX40 targeting shows therapeutic efficacy in preclinical studies. We report the monotherapy dose-escalation portion of a multicenter, phase I trial (NCT02315066) of ivuxolimab (PF-04518600), a fully human immunoglobulin G2 agonistic monoclonal antibody specific for human OX40.<h4>Patients and methods</h4>Adult patients (<i>N</i> = 52) with selected locally advanced or metastatic cancers received ivuxolimab 0.01 to 10 mg/kg. Primary endpoints were safety and toler2022-01-01T00:00:00Z2022 Jan2026-05-28T03:45:58.74Z2025-04-06T00:51:47.491ZS-EPMC94015023461572510.1158/1078-0432.CCR-21-0845