A Phase I, Open-label, Dose Finding, Safety, Tolerability and Exploratory Trial of THEO-260 Administered Via an Intraperitoneal Route in Patients With High Grade Serous or Endometrioid Ovarian Cancer
The goal of this clinical trial is to establish if THEO-260 is safe to administer to adult females with ovarian cancer. It will also aim to establish if THEO-260 is able to treat ovarian cancer. The main questions it aims to answer are: * What medical problems do participants have when taking THEO-260? * At what dose is THEO-260 both safe but also shows signs of being able to treat ovarian cancer? The clinical trial follows a dose escalation/ finding design where we will aim to establish a Recommended Phase 2 Dose (RP2D). Participants will: * Be administered 6 doses of THEO-260 via an intraperitoneal (IP) route of administration over the course of 2 weeks. * They will then visit the clinic at regular intervals for check-ups and tests to monitor safety and THEO-260 ability to treat ovarian cancer.
• Confirmed histological diagnosis of advanced high grade serous or endometrioid cancer of the fallopian tube, primary peritoneum or ovary either on archival biopsy or fresh tumour biopsy.
• Platinum-resistant or refractory disease: platinum-resistance is defined as radiological progression within 6 months of last cycle of platinum treatment; platinum refractory disease is defined as radiological progression during the 3 months following the first dose with platinum treatment.
• Voluntary, written informed consent prior to trial procedures. Willingness and ability to comply with the protocol.
• Life expectancy of \> 6 months.
• Adequate haematological and organ function (parameters apply).
• Non-pregnant and non-lactating and surgically sterile, or post-menopausal or abstinent or if of child-bearing potential will to use a highly effective form of contraception - where applicable.
• ECOG performance status of 0 or 1.
• Measurable disease as per RECIST V1.1.