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• W3088008220 abstract "CD39, an extracellular enzyme, is overexpressed in the tumor microenvironment, on both tumor infiltrating cells and stromal cells in several cancer types. CD39 promotes immunosuppression by degrading adenosine triphosphate (ATP) into adenosine monophosphate (AMP), that is then further degraded into adenosine by CD73. IPH5201, an anti-CD39 blocking monoclonal antibody, has the potential to promote accumulation of immune-stimulatory ATP and reduce the formation of immunosuppressive adenosine, thereby leading to increased antitumor immunity for multiple tumor types. Preclinical studies demonstrated that IPH5201, in combination with PD-L1 checkpoint inhibitors, increased antitumor efficacy versus a PD-L1 inhibitor alone. This is a phase I, first-in-human, multicenter, open-label, dose-escalation study of IPH5201 as monotherapy or in combination with durvalumab (anti–PD-L1) ± oleclumab (anti-CD73) in patients with advanced solid tumors. Eligible subjects are aged ≥18 years, with advanced solid tumors, and an ECOG PS of ≤1, no conventional or investigational anticancer therapy (eg, anti–CTLA-4, anti–PD-1, anti–PD-L1 antibodies) within 21 days prior to the first dose and no prior agents targeting CD73, CD39, or adenosine receptors. The study will consist of 3 distinct dose-escalation parts given every 3 weeks: IPH5201 monotherapy (part 1), IPH5201 + durvalumab (anti–PD-L1; part 2), and IPH5201 + durvalumab + oleclumab (anti-CD73; part 3). Dose escalation will be based on an m-TPI-2 algorithm of 3 to 12 subjects per cohort. For parts 1 and 2, additional pharmacodynamic cohorts will enroll 6 to 12 subjects at a specific dose with mandatory paired biopsies. The primary endpoint will evaluate safety and tolerability and determine the MTD of IPH5201 in monotherapy and in combination with durvalumab +/- oleclumab. Secondary endpoints will evaluate preliminary antitumor activity and characterize pharmacokinetics and immunogenicity. Up to 204 subjects will be enrolled in the United States, France, Spain, and Switzerland. NCT04261075. Medical writing support, conducted in accordance with Good Publication Practice (GPP3) and the International Committee of Medical Journal Editors (ICMJE) guidelines, was provided by Eli Berdougo, PhD of Oxford PharmaGenesis, Inc., Newtown, PA, and was funded by AstraZeneca. AstraZeneca. AstraZeneca." @default.
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• W3088008220 date "2020-09-01" @default.
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• W3088008220 title "1073TiP A phase I, first-in-human, multicenter, open-label, dose-escalation study of IPH5201 as monotherapy or in combination with durvalumab ± oleclumab in advanced solid tumours" @default.
• W3088008220 doi "https://doi.org/10.1016/j.annonc.2020.08.1193" @default.
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