Actively Recruiting
A Study of MOv18 IgE in Patients With Solid Tumours That Express Folate Receptor Alpha
Led by Epsilogen Ltd · Updated on 2026-04-06
45
Participants Needed
7
Research Sites
129 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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 patients aged 18 years or older
- Signed and dated informed consent
- Confirmed advanced, recurrent, or metastatic ovarian, endometrial, or triple-negative breast cancer
- Tumor tissue expressing folate receptor alpha on at least 5% of tumor cells confirmed by immunohistochemistry
- Negative basophil activation test before first MOv18 IgE dose
- Platinum-free interval less than 6 months for ovarian cancer patients
- Progression after prior therapies as appropriate for cancer type and no suitable authorized therapy available
- Measurable disease per RECIST v1.1 on CT or MRI within 28 days before first MOv18 IgE dose
- No evidence of bowel obstruction
- ECOG performance status of 0 or 1 prior to first MOv18 IgE dose
- Estimated life expectancy greater than 3 months
- Adequate hematological, immune, renal, and hepatic function as specified
- Recovery from chemotherapy-related toxicities to Grade 1 or lower (except alopecia and peripheral neuropathy)
- No significant cardiac or pulmonary dysfunction
- No active or recent autoimmune disease requiring immunosuppressive treatment
- Negative pregnancy test for women of childbearing potential
- Agreement to use effective contraception or true abstinence during and 6 months after treatment
- Willingness and ability to comply with study protocol and visit schedule
- Advised to minimize skin exposure to UV light during study and for 4 weeks after last dose
You will not qualify if you...
- Non-epithelial tumors of ovary, fallopian tube, or peritoneum
- Ascites or pleural effusion requiring drainage within 28 days before first dose or ongoing malignant effusion
- Use of beta-blockers or full-dose tricyclic antidepressants/MAOIs that cannot be discontinued
- History of laryngeal edema, uncontrolled asthma, or anaphylaxis
- Parasitic infections within 5 years
- Elevated serum tryptase or positive basophil activation test
- Receiving systemic anti-cancer therapy or radiotherapy within specified timeframes
- Concurrent chemotherapy, anti-cancer drugs, or radiotherapy during trial (except specified exceptions)
- Chronic systemic corticosteroid or immunosuppressive treatment within 14 days prior to first dose
- Recent live attenuated vaccine administration or planned vaccination during study
- Previous 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 infection or psychiatric illness
- Significant cardiovascular disease within past 12 months
- Use of drugs known to prolong QT interval
- Fever above 38°C within 3 days before first dose
- Other prior malignancies except specified treated cancers in remission
- CNS metastases or primary CNS tumor
- Recent major surgery or clinically significant illness
- Currently breastfeeding
- Any condition or treatment that may interfere with trial conduct or increase risk
- Legal custodianship
- First-degree relatives of study staff or sponsor employees
AI-Screening
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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
CONTACT
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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