RecruitingPhase 1NCT06547840

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

A Phase Ib, Open-Label Trial of MOv18 IgE in Patients With Solid Tumours That Overexpress Folate Receptor Alpha


Sponsor

Epsilogen Ltd

Enrollment

45 participants

Start Date

Sep 3, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new type of antibody drug called MOv18 IgE in women with platinum-resistant ovarian cancer whose tumors express a protein called folate receptor alpha (FRα). "Platinum-resistant" means the cancer stopped responding to standard platinum-based chemotherapy. This drug uses a novel approach — it works through the immune system's IgE antibody pathway — which is different from most cancer antibodies currently available. **You may be eligible if...** - You are a woman aged 18 or older - You have advanced ovarian cancer, fallopian tube cancer, or primary peritoneal cancer of the high-grade serous or endometrioid type - Your tumor has tested positive for the FRα protein (confirmed by biopsy or tissue sample) - Your cancer has continued to grow despite platinum-based chemotherapy - You are in reasonable physical health **You may NOT be eligible if...** - You have never had a tissue sample tested for FRα expression or are unwilling to provide one - You have a known allergy to the study drug components - You have uncontrolled infections or certain serious medical conditions - You have active autoimmune disease or are on immunosuppressive therapy - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGMOv18 IgE

MOv18 IgE is an anti-FRα monoclonal antibody (mAb) of the IgE class


Locations(7)

Bristol Haematology and Oncology Centre

Bristol, United Kingdom

Edinburgh Cancer Research Centre

Edinburgh, United Kingdom

Leeds Teaching Hospitals NHS Trust

Leeds, United Kingdom

Cambridge University - Addenbrooke's Hospital

London, United Kingdom

University College London Hospital

London, United Kingdom

Guy's Hospital

London, United Kingdom

University Hospital Southampton NHS Foundation Trust

Southampton, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT06547840


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