- A Study of MOv18 IgE in Patients With Solid Tumours That Express Folate Receptor Alpha — Recruiting • Phase I • Oncology • NCT06547840.
- 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….
- Sponsor: Epsilogen Ltd.
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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…
- : Patients must meet all of the following criteria: 1. Female ≥18 years of age. 2. Written (signed and dated) informed consent. 3. 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 3 months, in the opinion of the Investigator. 12. 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…
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