A Phase I/IIa, Open-label, Dose Finding, Safety, Tolerability and Exploratory Trial of THEO-260 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? * At the selected dose, test THEO-260 is a wider group of participants to confirm the safety and ability to treat ovarian cancer. Part A will be the dose escalation/ finding part of the trial where we will aim to establish a Recommended Phase 2 Dose (RP2D). Part B will be where the recommended RP2D is given to a larger group of participants. Participants will: * Be administered 6 doses of THEO-260 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.
• Voluntary, written informed consent prior to trial procedures. Willingness and ability to comply with the protocol.
• Life expectancy of \> 3 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.
• Part A: Platinum-resistant disease (radiological recurrence/ progression with 6 months of prior platinum treatment), primary platinum-refractory disease (recurrence/ progression during first line platinum treatment) and patients who are intolerant to or have no available SOC or SOC unacceptable/ unsuitable in the view of the Investigator. Part B: Advanced platinum-resistant disease: platinum-resistance as radiological recurrence/ progression within 6 months of prior platinum treatment or progression on SOC treatment or in intolerant to or has no available SOC or SOC unacceptable/ unsuitable in the view of the Investigator.