Study design
toxicity, ovarian cancer, tumour, Cancer
DISEASE PROGRESSION, TUMOUR, OVARIAN CANCER, CANCER
This was an open-label, dose-escalating Phase I study of MOv18 IgE conducted at 4 sites in the United Kingdom. The study was undertaken under the sponsorship and management of the Cancer Research UK Centre for Drug Development, conducted in accordance with International Council for Harmonisation Good Clinical Practice guidelines and ethical principles of the Declaration of Helsinki, and approved by the UK Medicines and Healthcare products Regulatory Agency and National Health Service Health Research Authority (EudraCT number 2014-000070-19; ClinicalTrials.gov identifier NCT02546921, first registered 11 September 2015). Participants provided written informed consent prior to the conduct of any study procedures. Antibody was administered as an intravenous infusion weekly for a six-week treatment period. In the absence of disease progression or intolerable treatment-related toxicity, patients were offered the option to continue two-weekly dosing for a further maintenance period.Screening tests at baseline included physical examination, computerised tomography (CT), standard tests of organ function, beta-tryptase, endogenous IgE level, tumour FRα expression, basophil activation test, and intradermal or skin-prick test. Safety assessments were repeated prior to each further dose throughout the study. All patients receiving at least 1 intravenous dose of MOv18 IgE were evaluable for safety. Anti-tumour activity was assessed using standard tumour markers where relevant (for example, CA125 in ovarian cancer cases), and CT according to RECIST version 1.1 at intervals of 6 weeks. Laboratory endpoints were analysed using SSPS version 29 and presented with Graphpad Prism version 9.5.