Phase Ib Study of MOv18 IgE Treatment in Women with Advanced Ovarian, Endometrial, or Triple-Negative Breast Cancer Expressing Folate Receptor Alpha

What this Trial Is About

Researchers are evaluating MOv18 IgE, an anti-Folate Receptor alpha FR monoclonal antibody, in patients with platinum resistant ovarian cancer and other solid tumours expressing FR at 5% or higher. This Phase Ib, open-label trial includes dose escalation to find the maximum tolerated or administered dose, followed by dose expansion to further assess safety, tolerability, and preliminary anti-tumour activity. Around 45 patients with measurable disease and confirmed FR expression will participate. MOv18 IgE is given by intravenous infusion on Days 1, 8, and 15 of a 21-day cycle. Part 1 involves dose escalation starting at 3 mg in cohorts of about 6 patients using a Bayesian design to identify the recommended dose for Part 2. Part 2 enrolls up to 15 patients to receive MOv18 IgE at the selected dose to further evaluate anti-tumour effects and safety. Treatment continues until disease progression, unacceptable toxicity, withdrawal, death, or study termination. Participants will undergo screening within 28 days before treatment start, including tumour biopsy confirmation, pharmacokinetic, pharmacodynamic, safety, and tumour response assessments. They will be followed for overall survival for up to 270 days post-treatment or until withdrawal, loss to follow-up, death, or study end. The trial includes regular clinical and laboratory monitoring to evaluate safety, tolerability, and treatment impact.

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