Phase I, open-label, dose finding, safety, tolerability and exploratory study of THEO-260 in patients with high grade serous or endometrioid ovarian cancer (OCTOPOD)

Research summary

This is a multi-centre, open label, FIH, multi-part trial to assess safety, tolerability, and preliminary efficacy of THEO-260 in patients with high grade serous or endometrioid ovarian cancer. The trial consists of 4 parts: Part A, Part B, Part C (optional) and Part D (optional). Part A (Dose Escalation/Finding Part): The trial part will use a model-assisted methodology for dose finding, Bayesian Optimal Interval (BOIN). Four (4) escalating dose levels are planned. In Part A, RP2D will be identified. Up to 18 participants (up to 6 dose level cohorts with 3 participants in each) with high grade serous or endometrioid cancer of the fallopian tube, primary peritoneum or ovary will be enrolled in Part A. Part B (Dose Expansion Part): The trial part to explore efficacy of THEO-260 in patients with high grade serous or endometrioid cancer of the fallopian tube, primary peritoneum or ovary. Ten (10) participants will be enrolled in Part B and will receive THEO-260 at the RP2D identified in Part A. The sample size for Part B may be increased, if supported by the emerging data. The Safety Review Committee (SRC) will make the recommendation to increase the sample size following the review of the first 10 participants. Part C (Mechanism-of-Action Part; Optional): The trial part to explore the mechanism-of-action of THEO-260 with the aim to collect and analyse tissue samples from patients with ovarian cancer exposed to THEO-260 who subsequently undergo a second surgical debulking as part of standard-of-care (SOC). Number of participants, objectives and other details for Part C will be added via a substantial amendment. Part D (Intraperitoneal Dosing Part; Optional): The trial part to explore an alternative route of administration of THEO-260. Intraperitoneal dosing has emerged as a potentially safe and efficacious route of administration. Number of participants, objectives and other details for Part D will be added via a substantial amendment.

Principal Investigator

Prof Sarah Blagden

Contact us

Email: orh-tr.earlyphasenurses@nhs.net

IRAS number

1007880