ArticleESMO open2026
First-in-human study of intravenous bispecific CTLA-4 × OX40 antibody (ATOR-1015) in advanced solid malignancies.
Article in ESMO open, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
backgroundIpilimumab, a monoclonal antibody against cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), was the first approved checkpoint inhibitor; however, its use is hampered by treatment-related adverse events (TRAEs). ATOR-1015 is a bispecific antibody targeting CTLA-4 and OX40 designed to direct the effect to the tumor microenvironment and thereby improve the response rate and reduce TRAEs. MATERIALS AND
methodsWe conducted a phase I, first-in-human, multicenter study to determine the safety and tolerability of intravenously administered ATOR-1015 every second week. Secondary objectives were efficacy and pharmacokinetics. An exploratory objective was to investigate the pharmacodynamic effects on the immune system. Twenty-eight patients with advanced solid cancer were treated in the last line with ATOR-1015. A modified 3 + 3 dose-escalation design was applied.
resultsThe most common TRAEs were infusion-related reactions (IRRs) (n = 14, 50.0%), pyrexia (n = 3, 10.7%), myalgia (n = 3, 10.7%) and rash (n = 3, 10.7%). One serious AE occurred (grade III IRR). Best response (according to immune RECIST) was stable disease (n = 11, 39.3%), which lasted >4 months in six patients (21.4%). These patients showed a significant increase in inducible T-cell costimulator-expressing CD4+ and CD8+ central memory T cells 4 h after infusion. In all patients, temporary elevations in absolute lymphocyte count, B cells and T cells as well as interleukin-8, interferon-γ and tumor necrosis factor-α were observed.
conclusionsAlthough considered safe, the treatment induced neutralizing anti-drug antibodies in most patients, leading to IRRs and reduced efficacy due to low serum exposure, an effect that could not be overcome by increasing doses. Future development requires re-engineering the therapeutic format to minimize immunogenicity, thereby improving both safety and effectiveness.
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