Actively Recruiting
A Phase Ib, Open-Label Trial of MOv18 IgE in Patients With Solid Tumours That Overexpress Folate Receptor Alpha
Led by Epsilogen Ltd · Updated on 2026-04-06
45
Participants Needed
7
Research Sites
34 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating MOv18 IgE, an anti-Folate Receptor alpha (FRα) monoclonal antibody, in patients with platinum resistant ovarian cancer and other solid tumours expressing FRα 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 FRα 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.
CONDITIONS
Brief Title
A Study of MOv18 IgE in Patients With Solid Tumours That Express Folate Receptor Alpha
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female aged 18 years or older
- Signed informed consent
- Histologically or cytologically confirmed advanced, recurrent or metastatic ovarian cancer, endometrial cancer, or triple-negative breast cancer meeting specific subtype and biomarker criteria
- Tumour tissue expressing folate receptor alpha on at least 5% of tumour cells confirmed by immunohistochemistry
- Negative basophil activation test prior to first treatment
- For ovarian cancer, platinum-free interval since last platinum dose less than 6 months
- Prior therapies: progressed after specific prior treatments with no other authorized therapy appropriate
- Measurable disease by RECIST v1.1 on CT or MRI
- No evidence of bowel obstruction
- ECOG Performance Status 0-1
- Estimated life expectancy greater than 3 months
- Adequate hematological, immune, renal, and hepatic function as specified
- Recovered from chemotherapy toxicities to Grade 1 or better
- No significant cardiac or pulmonary dysfunction
- No active or recent autoimmune disease requiring immunosuppression
- Negative pregnancy tests and use of effective contraception for women of childbearing potential
- Willing and able to comply with protocol assessments and visit schedule
- Advised to avoid or minimize UV light exposure during and 4 weeks after treatment
You will not qualify if you...
- Non-epithelial tumours of ovary, fallopian tube, or peritoneum
- Ascites or pleural effusion requiring drainage or persistent malignant effusions
- Use of beta-blockers or certain antidepressants that cannot be interrupted
- History of laryngeal oedema, uncontrolled asthma, or anaphylaxis
- History of parasitic infections within 5 years
- Baseline elevation of serum tryptase or positive basophil activation test
- Recent systemic anti-cancer therapy within 28 days
- Concurrent chemotherapy, anti-cancer therapy, or radiotherapy during study
- Recent radiation therapy within 14 days prior to treatment
- Chronic systemic corticosteroid or immunosuppressive therapy within 14 days
- Recent live attenuated vaccine within 28 days prior to treatment or planned during trial
- Previous allogeneic bone marrow or solid organ transplant
- Positive HIV serology
- History of interstitial lung disease or active pneumonitis
- Known hypersensitivity to MOv18 IgE or its components
- Positive hepatitis B or C serology
- Uncontrolled illness including infection or psychiatric illness
- Significant cardiovascular disease within last 12 months
- Use of drugs known to prolong QT/QTc interval
- Fever above 38°C within 3 days before treatment
- Other prior malignancies except specific treated cancers
- CNS metastases or primary CNS tumour
- Recent major surgery or clinically significant illness
- Currently breastfeeding
- Conditions or treatments that interfere with trial conduct or increase risk
- Under legal custodianship
- First-degree relatives of Investigator, trial staff, or Sponsor employees
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 28 days prior to first treatment
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for initial screening assessments
Duration - Repeated 21-day cycles until disease progression or unacceptable toxicity
Participants receive MOv18 IgE by intravenous infusion on Days 1, 8, and 15 of each 21-day cycle. Treatment continues until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
3 visits per cycle (in-person) for drug administration
Duration - Up to 270 days after last treatment dose
Participants are followed for overall survival and safety for up to 270 days after the last dose of MOv18 IgE or until withdrawal of consent, lost to follow-up, death, or study end.
Visits scheduled as per protocol for survival and safety monitoring
Trial Site Locations
Total: 7 locations
1
Bristol Haematology and Oncology Centre
Bristol, United Kingdom, BS2 8ED
Actively Recruiting
2
Edinburgh Cancer Research Centre
Edinburgh, United Kingdom, EH4 2XR
Actively Recruiting
3
Leeds Teaching Hospitals NHS Trust
Leeds, United Kingdom, LS9 7LP
Actively Recruiting
4
Cambridge University - Addenbrooke's Hospital
London, United Kingdom, CB2 0QQ
Actively Recruiting
5
University College London Hospital
London, United Kingdom, NW1 2BU
Actively Recruiting
6
Guy's Hospital
London, United Kingdom, SE1 3SS
Actively Recruiting
7
University Hospital Southampton NHS Foundation Trust
Southampton, United Kingdom, SO16 6HU
Actively Recruiting
Research Team
E
Epsilogen Clinical Trials
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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