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New treatment option for Advanced Ovarian Cancer
Official title A Study of MOv18 IgE in Patients With Solid Tumours That Express Folate Receptor Alpha
ClinicalTrials.gov ID: NCT06547840
What this study is testing
What is MOv18 IgE?
MOv18 IgE is an investigational medicine, being studied as a potential treatment for advanced ovarian cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join 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...
- HER2-negative in situ hybridization test or an immunohistochemistry (IHC) status of 0 or 1+
You likely can't join 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...
- Taking beta-blockers (at PI discretion) and unable to interrupt beta-blockade (which may counteract the therapeutic effects of adrenaline), or full...
- History of laryngeal oedema, uncontrolled or high-risk asthma, or anaphylaxis. Patients with a history of hypersensitivity to carboplatin, taxanes...
- History of parasitic infections, such as helminthiasis within 5 years of the first administration of MOv18 IgE.
See the full eligibility criteria
Who can join
- 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...
- 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...
- 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...
- 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...
- 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...
- Intact immune system as demonstrated by CD4 count ≥500 cells/mm3 and CD8 count ≥150 cells/mm3.
- Adequate renal function as demonstrated by either estimated glomerular filtration rate [eGFR] or calculated creatinine clearance \>45 mL/min (Cockcroft Gault equation: creatinine clearance: (140-age [years]) × weight...
- Adequate hepatic function: i. Serum total bilirubin ≤1.5 × ULN or direct bilirubin ≤ ULN for a patient with total bilirubin levels \>1.5 × ULN. ii. AST (SGOT) and ALT (SGPT) ≤2.5 × ULN or ≤5 × ULN for a patient with...
- Recovered from all chemotherapy-related toxicities to Grade ≤1 according to CTCAE v5.0, excluding alopecia (any grade) and peripheral neuropathy (Grade ≤2).
- No history of significant cardiac or pulmonary dysfunction, including but not limited to interstitial pulmonary disease and chronic obstructive pulmonary disease.
- No active or history of autoimmune disease, (with exception of vitiligo, type I DM, residual hypothyroidism due to autoimmune condition only requiring hormone replacement) and/or no history of autoimmune disease that...
- Negative serum or urine pregnancy test.
- Women of childbearing potential must have 2 negative pregnancy tests during Screening, the second within 24 hours prior to the first administration of MOv18 IgE. This criterion does not apply to patients who have had a...
- Female patients of child bearing potential must agree to practice true abstinence or to use two forms of contraception, one of which must be highly effective. These forms of contraception must be used from the time of...
- Willing and able to comply with all protocol-specified assessments and the trial visit schedule.
- Patient has been advised to take measures to avoid or minimise exposure of the skin to UV light, including sunbathing and solarium use for the duration of the trial and for 4 weeks following last administration of MOv18...
What rules you out
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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.
- Currently breastfeeding.
- Any condition which could interfere with, or the treatment for which might interfere with, the conduct of the trial, or which would, in the opinion of the Investigator, unacceptably increase the patient's risk by...
- Patient is under legal custodianship.
- First-degree relatives of the Investigator, trial staff or Sponsor employees.
The study team makes the final eligibility decision.
Where it's taking place
- Bristol, United Kingdom
- Edinburgh, United Kingdom
- Leeds, United Kingdom
- London, United Kingdom
- Southampton, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bristol, United Kingdom; Edinburgh, United Kingdom; Leeds, United Kingdom; London, United Kingdom; Southampton, United Kingdom. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.