EPS101-10-02 is a Phase Ib open label, multicentre clinical trial comprising of a Dose Escalation phase (Part 1) followed by a Dose Expansion phase (Part 2) of MOv18 IgE in patients with folate receptor alpha-expressing (5% or higher) platinum resistant ovarian cancer
The dose escalation part of the study will primarily assess the safety and tolerability of MOv18 IgE in ascending dose cohorts, until the determination of the maximum tolerated dose (MTD) or maximum administered dose (MAD).
Part 2 (dose expansion) will further assess the safety, tolerability and anti-tumour activity of MOv18 IgE.
Female ≥18 years of age.
Written (signed and dated) informed consent.
HER2-negative in situ hybridization test or an immunohistochemistry (IHC) status of 0 or 1+
ER and PgR expressions <10% as determined locally by IHC assay as per most recent ASCO/CAP guidelines
Non-epithelial tumour of the ovary, the fallopian tube, or the peritoneum (including germ cell tumours and sarcomas).
Presence of ascites/pleural effusion requiring drainage within 28 days of first dose MOv18 IgE or persistent ongoing malignant ascites or pleural effusion requiring an in-dwelling drain.
Taking beta-blockers (at PI discretion) and unable to interrupt beta-blockade (which may counteract the therapeutic effects of adrenaline), or full dose tricyclic anti-depressants/MAOIs (which can dangerously augment the effects of adrenaline). These agents should be discontinued at least 4 half-lives before administration of the first dose of MOv18 IgE. Treatment may be reintroduced 48 hours post dose administration.
History of laryngeal oedema, uncontrolled or high-risk asthma, or anaphylaxis. Patients with a history of hypersensitivity to carboplatin, taxanes, or contrast media may enter the trial at the Investigator's discretion.
Single group
MOv18 IgE
DrugMOv18 IgE is an anti-FRα monoclonal antibody (mAb) of the IgE class
Part 1: To evaluate the safety and tolerability of MOv18 IgE
Safety will be assessed by the incidence of AEs, SAEs and laboratory abnormalities characterized by type, incidence, and severity graded according to NCI CTCAE v5.0, seriousness, and relationship to study treatment.
Part 1: To determine the MTD or MAD of MOv18 IgE
Determination of the highest dose level where the predicted probability of being in the excessive toxicity/overdosing interval (30%-100% toxicity) is less than 0.25, and the predicted probability of being in the target toxicity interval (20%-30% toxicity) is greater than 50%.
Part 1: To determine the recommended Part 2 expansion dose of MOv18 IgE for future dose expansion cohorts
Establish the recommended Part 2 dose of MOv18 IgE when administered for the dose expansion phase, assessed by the incidence of AEs, SAEs and laboratory abnormalities characterized by type, incidence, and severity graded according to NCI CTCAE v5.0, seriousness, and relationship to study treatment. In addition to, pharmacokinetics and pharmacodynamics in blood or tissue.
Part 2: To make a preliminary assessment of the anti-tumour activity of MOv18 IgE at the selected dose
Assessment of anti-tumour activity as defined by RECIST version 1.1 and/or iRECIST, in addition to Best Gynecologic Cancer InterGroup (GCIG) overall response, combining the change in CA 125 from baseline with RECIST assessment (per GCIG, 2005)
Part 1: To document possible anti-tumour activity during dose escalation
Assessment of anti-tumour activity as defined by RECIST version 1.1and/or iRECIST
Part 2: To make a preliminary assessment of the ability of MOv18 IgE at the selected dose to delay disease progression
Assessment of anti-tumour activity as defined by RECIST version 1.1and/or iRECIST
Part 2: To further characterise safety and tolerability of MOv18 IgE at the selected dose
Safety will be assessed by the incidence of AEs, SAEs and laboratory abnormalities characterized by type, incidence, and severity graded according to NCI CTCAE v5.0, seriousness, and relationship to study treatment.
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