A Study of MOv18 IgE in Folate Receptor Alpha-expressing Platinum Resistant Ovarian Cancer
NCT Number: NCT06547840
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Advanced Ovarian Cancer|Platinum-resistant Ovarian Cancer
Interventions: DRUG: MOv18 IgE
Sponsor: Epsilogen Ltd
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 45
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2027-03
Locations: Bristol Haematology and Oncology Centre, Bristol, BS2 8ED, United Kingdom|Edinburgh Cancer Research Centre, Edinburgh, EH4 2XR, United Kingdom|Leeds Teaching Hospitals NHS Trust, Leeds, LS9 7LP, United Kingdom|Cambridge University - Addenbrooke's Hospital, London, CB2 0QQ, United Kingdom|University College London Hospital, London, NW1 2BU, United Kingdom|Guy's Hospital, London, SE1 3SS, United Kingdom|University Hospital Southampton NHS Foundation Trust, Southampton, SO16 6HU, United Kingdom

Summary:
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.

Primary Outcome Measures: 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., 1.5 years|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%., 1.5 years|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., 1.5 years|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 as assessed by BICR, in addition to Best Gynecologic Cancer InterGroup (GCIG) overall response, combining the change in CA 125 from baseline with RECIST assessment (per GCIG, 2005), 1 year
Secondary Outcome Measures: 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 as assessed by BICR, 1.5 years|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 as assessed by BICR, 1 year|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., 1 year