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

Recruiting now · Phase 1

Conditions studied: Advanced Ovarian Cancer, Platinum-resistant Ovarian Cancer, Triple Negative Breast Cancer (TNBC), Triple -Negative Breast Cancer, Endometrial Cancer, Advanced Endometrial Cancer

In brief

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.

Key facts

Study ID

NCT06547840

Run by

Epsilogen Ltd

People needed

45

Starts

2024-09-03

Expected to finish

2027-03-01

Last updated by the study team

2026-04-06

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Patients must meet all of the following criteria:
• Female ≥18 years of age.
• Written (signed and dated) informed consent.
• Histologically or cytologically confirmed advanced, recurrent or metastatic ovarian cancer, endometrial cancer, triple-negative breast cancer i. Ovarian cancer: must have epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer with high-grade serous or endometrioid features or a predominantly serous/endometrioid component ii. Endometrial cancer: must have advanced, recurrent or metastatic, endometrial cancer (any subtype excluding endometrial sarcoma) iii. Triple Negative Breast cancer: must have advanced, recurrent or metastatic triple-negative breast cancer (based on the most recently analyzed biopsy from locally recurrent or metastatic site, local laboratory) meeting the following criteria:
• HER2-negative in situ hybridization test or an immunohistochemistry (IHC) status of 0 or 1+
• ER and PgR expressions <10% as determined locally by IHC assay as per most recent ASCO/CAP guidelines
• Tumour tissue expressing FRα on at least 5% of tumour cells, as determined by immunohistochemistry using either (i) the BN3.2 antibody (Leica Biosystems) or (ii) the FOLR1 (FOLR1-2.1) antibody (Ventana) Note: All patients must be willing to provide an archival tumour tissue block, or undergo a procedure to obtain a new biopsy, using a low risk, medically routine procedure for immunohistochemistry (IHC) confirmation of FRα positivity using BN3.2 antibody (Leica Biosystems).
• Note: Pre-screening for FRα positivity, using BN3.2 antibody (Leica Biosystems), may be performed at any point in advance of the first administration of MOv18 IgE i. Leica Biosystems BN3.2 antibody 1+ 2+ 3+ staining ii. Ventana FOLR1 antibody criteria 2+ 3+ membrane staining Note: Patients with a medical history confirming tumour tissue expression of FRα, as confirmed by the Ventana FOLR1 antibody, will be considered as meeting inclusion Criteria #4 and will not require a confirmation via Leica Biosystems assay prior to receiving MOv18 IgE. However, in all instances, confirmation of FRα expression using the BN3.2 antibody (Leica Biosystems), will be required to be tested during the trial. Confirmation is not required prior to C1D1.
• Note: Discordant results between the two systems will not result in patient removal from the trial unless deemed appropriate by the treating Investigator.
• Negative basophil activation test (BAT) prior to the first administration of MOv18 IgE.
• Note: this test will be performed at a reference laboratory.
• Ovarian cancer: platinum-free interval since last dose of platinum, of less than 6 months (182 days).
• Prior therapies:
• Ovarian cancer: progressed following ≤2 prior regimens of anti-cancer therapy for platinum resistant ovarian cancer, and, at the time, no other authorised therapy is considered appropriate by the treating investigator.
• i. Patients who received hyperthermic intraperitoneal chemotherapy (HIPEC) or other IP therapies are eligible.
• Endometrial cancer: progressed after any prior line of systemic therapy, and, at the time, no other authorised therapy is considered appropriate by the treating investigator.
• Breast cancer: progressed after any prior line of systemic therapy, and, at the time, no other authorised therapy is considered appropriate by the treating investigator.
• Has measurable disease as defined by RECIST v1.1 on CT or MRI scan i. Note: Baseline scans must be performed ≤28 days before the first administration of MOv18 IgE, after discontinuation of the prior regimen.
• ii. Note: Lesions previously embolised, perfused, or irradiated without objective evidence of progression before the first administration of MOv18 IgE are not allowed to be considered for response assessment.
• No evidence of bowel obstruction.
• ECOG Performance Status Score 0-1 prior to the first administration of MOv18 IgE.
• Estimated life expectancy of >3 months, in the opinion of the Investigator.
• Adequate haematological function, including all of the following:
• i. Absolute neutrophil count (ANC) ≥1.5 × 109/L (>1,500/mm3). G-CSF or GM-CSF may not be used to achieve this level.
• ii. Platelets ≥100 × 109/L (>100,000 per mm3) iii. Haemoglobin level >9 g/dL obtained within 14 days before the first administration of MOv18 IgE. Packed red blood cell transfusion is acceptable, if the patient has a stable result of ≥9 g/dL for at least 1 week post-transfusion. Erythropoietin should not be used to achieve this level.

You may not qualify if…

• Patients must not meet any of the following criteria:
• Non-epithelial tumour of the ovary, the fallopian tube, or the peritoneum (including germ cell tumours and sarcomas).
• Presence of ascites/pleural effusion requiring drainage within 28 days of first dose MOv18 IgE or persistent ongoing malignant ascites or pleural effusion requiring an in-dwelling drain.
• Taking beta-blockers (at PI discretion) and unable to interrupt beta-blockade (which may counteract the therapeutic effects of adrenaline), or full dose tricyclic anti-depressants/MAOIs (which can dangerously augment the effects of adrenaline). These agents should be discontinued at least 4 half-lives before administration of the first dose of MOv18 IgE. Treatment may be reintroduced 48 hours post dose administration.
• i. Note: Beta blockers may continue if, in the opinion of the Investigator, it would not pose additional risk to the patient ii. Note: Only applies to full dose tricyclic anti-depressants. Low dose tricyclic anti-depressants to support conditions such as peripheral neuropathy, chronic pain, or insomnia, may be permitted at PI discretion
• History of laryngeal oedema, uncontrolled or high-risk asthma, or anaphylaxis. Patients with a history of hypersensitivity to carboplatin, taxanes, or contrast media may enter the trial at the Investigator's discretion.
• History of parasitic infections, such as helminthiasis within 5 years of the first administration of MOv18 IgE.
• Baseline elevation in serum tryptase (indicating possible mastocytosis) or a positive BAT. Tryptase normal range is 2-15 ng/mL.
• Receiving systemic anti-cancer therapy, including immunostimulatory agents (e.g., cytokine-based modality, antigen-specific peptide immunotherapy, immune checkpoint blockade, co-stimulatory agonists) within 28 days of the first administration of MOv18 IgE.
• Administration of other simultaneous chemotherapy drugs, anti-cancer therapy or anti-neoplastic hormonal therapy, or simultaneous radiotherapy during the trial treatment period (hormonal replacement therapy and denosumab is permitted).
• Receiving radiation therapy within 14 days prior to the first administration of MOv18 IgE. Local palliative radiotherapy is permitted; however, if the radiotherapy is to a target lesion, that lesion must be excluded from tumour response assessments.
• Chronic treatment with systemic corticosteroids or other systemic immunosuppressive medications (including but not limited to prednisone (>10 mg), cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-TNF agents) within 14 days prior to the first administration of MOv18 IgE, or anticipated requirement for systemic immunosuppressive medications during the trial.
• Administration of a live, attenuated vaccine within 28 days prior to Day 1 or anticipation that such a live attenuated vaccine will be required during the trial or within 5 months, (152 days), after the last dose of MOv18 IgE. Influenza vaccination should be given during influenza season only. Patients must not receive live, attenuated influenza vaccination. COVID vaccination is permitted as necessitated.
• Previous allogeneic bone marrow transplant or previous solid organ transplantation.
• Historical positive serology test for human immunodeficiency virus (HIV).
• History of interstitial lung disease or active pneumonitis.
• Has a known hypersensitivity to a component of protocol therapy, MOv18 IgE or its vehicle (sodium citrate, L-arginine, sucrose and polysorbate 20).
• Positive serology for hepatitis B or C.
• Uncontrolled concurrent illness including, but not limited to, ongoing or active infection, or psychiatric illness.
• Has a history within last 12 months or ongoing clinically significant cardiovascular disease such as unstable angina, myocardial infarction, or acute coronary syndrome, symptomatic or uncontrolled arrhythmia, left ventricular failure, congestive heart failure, baseline ECG abnormalities that, in the Investigator's opinion, would be likely to interfere with their participation in the study, or with the interpretation of the results, including, but not limited to, QTc prolongation to greater than 470 ms (as determined by the Fridericia formula), or any Class III or IV cardiac disease as defined by the New York Heart Association Functional Classification.
• Concomitant use of drugs known to prolong QT/QTc interval (Appendix 1).
• Has a fever ≥38oC within 3 days before the first dose of MOv18 IgE.
• No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in-situ cervical cancer, surgically treated Stage I or II cancer from which the patient is currently in complete remission (at least to 5 years), or any other non-metastatic cancer controlled by surgery alone or surgery plus radiotherapy from which the patient has been disease-free for 5 years.
• Presence of CNS metastases (including spinal metastases) or CNS primary tumour, e.g., glioblastoma.
• Clinically significant illness or major surgery within 4 weeks before the administration of MOv18 IgE.

Where it is running

• Bristol Haematology and Oncology Centre — Bristol, United Kingdom (enrolling)
• Edinburgh Cancer Research Centre — Edinburgh, United Kingdom (enrolling)
• Leeds Teaching Hospitals NHS Trust — Leeds, United Kingdom (enrolling)
• Cambridge University - Addenbrooke's Hospital — London, United Kingdom (enrolling)
• University College London Hospital — London, United Kingdom (enrolling)
• Guy's Hospital — London, United Kingdom (enrolling)
• University Hospital Southampton NHS Foundation Trust — Southampton, United Kingdom (enrolling)

Full record on ClinicalTrials.gov

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