A Study of MOv18 IgE in Patients With Solid Tumours That Express Folate Receptor Alpha

EPS101-10-02 is a two-part, Phase Ib, open-label, dose escalation and expansion trial in patients with platinum resistant ovarian cancer whose disease has progressed after no more than 4 lines of standard therapy.

In total, the trial will enrol approximately 45 patients. All enrolled patients will have biopsy accessible, measurable disease with a confirmed FRα expression of 5% or higher.

MOv18 IgE will be administered to approximately 30 patients in Part 1 and up to a further 15 in Part 2.

Patients will receive treatment on Days 1, 8 and 15 of a 21-day cycle and may continue treatment until radiological disease progression or unacceptable toxicity despite optimal medical management or dose or schedule modification, or withdrawal of consent.

The starting dose of MOv18 IgE is 3 mg.

Patient screening will occur during the 28 days prior to the first administration of MOv18 IgE. All patients will undergo PK, PD and safety assessments, as well as disease response (tumour) assessments to determine the potential clinical benefit of MOv18 IgE. In all instances, patients will be followed up for overall survival (OS) for a maximum of 270 days after their last dose of trial treatment, or until withdrawal of consent, lost to follow-up, death, or the overall end of trial, whichever is earliest.

In Part 1, MOv18 IgE will be administered at increasing dose levels in different patient cohorts of approximately 6 patients, until selection of the Part 2 dose. The dose of MOv18 IgE administered in Part 1 will be escalated following a Bayesian logistic regression model - Escalation with overdose control (BLRM-EWOC) trial design.

After determination of the Part 2 dose, up to 15 additional patients will be enrolled and treated with MOv18 IgE at that dose to further assess anti-tumour activity of MOv18 IgE and obtain additional information on its safety, PK and PD.