biostudies-literatureSpicer JCancer Research UKMedical Research CouncilNational Institute for Health Research (NIHR)4180https://www.ebi.ac.uk/biostudies/studies/S-EPMC10368744biostudies-literatureUnknown14(1)All antibodies approved for cancer therapy are monoclonal IgGs but the biology of IgE, supported by comparative preclinical data, offers the potential for enhanced effector cell potency. Here we report a Phase I dose escalation trial (NCT02546921) with the primary objective of exploring the safety and tolerability of MOv18 IgE, a chimeric first-in-class IgE antibody, in patients with tumours expressing the relevant antigen, folate receptor-alpha. The trial incorporated skin prick and basophil activation tests (BAT) to select patients at lowest risk of allergic toxicity. Secondary objectives were exploration of anti-tumour activity, recommended Phase II dose, and pharmacokinetics. Dose escalation ranged from 70 μg-12 mg. The most common toxicity of MOv18 IgE is transient urticaria. A singleNature communicationsSafety and anti-tumour activity of the IgE antibody MOv18 in patients with advanced solid tumours expressing folate receptor-alpha: a phase I trial.PMC10368744N/A11060C604/A25135RP-2016-07-028NIHR205044MR/L023091/1Montes AChauhan JBarton CStavraka CIlieva KMMiller RGillett CBasu BMellor SSelkirk CFuningana IGKristeleit RFigini MGould HJDoherty GTill SJPinder SNakamura MBax HJSpicer JBanerji UKaragiannis SNPellizzari GKhiabany ACanevari SVeal GJJosephs DHJones PNintos GCarroll SCorrigan CJKwatra VfalseSafety and anti-tumour activity of the IgE antibody MOv18 in patients with advanced solid tumours expressing folate receptor-alpha: a phase I trial.All antibodies approved for cancer therapy are monoclonal IgGs but the biology of IgE, supported by comparative preclinical data, offers the potential for enhanced effector cell potency. Here we report a Phase I dose escalation trial (NCT02546921) with the primary objective of exploring the safety and tolerability of MOv18 IgE, a chimeric first-in-class IgE antibody, in patients with tumours expressing the relevant antigen, folate receptor-alpha. The trial incorporated skin prick and basophil activation tests (BAT) to select patients at lowest risk of allergic toxicity. Secondary objectives were exploration of anti-tumour activity, recommended Phase II dose, and pharmacokinetics. Dose escalation ranged from 70 μg-12 mg. The most common toxicity of MOv18 IgE is transient urticaria. A single2023-01-01T00:00:00Z2023 Jul2026-05-29T10:18:47.952Z2025-04-07T04:18:05.083ZS-EPMC103687443749137310.1038/s41467-023-39679-9