OncoMatch/Clinical Trials/NCT06618235
Trial of THEO-260 in Ovarian Cancer Patients
Is NCT06618235 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies THEO-260 for ovarian cancer.
Treatment: THEO-260 — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Ovarian Cancer
Disease stage
Grade: high grade
Confirmed histological diagnosis of advanced high grade serous or endometrioid cancer of the fallopian tube, primary peritoneum or ovary
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: platinum-based chemotherapy
Platinum-resistant disease (radiological recurrence/ progression with 6 months of prior platinum treatment), primary platinum-refractory disease (recurrence/ progression during first line platinum treatment)
Cannot have received: group B adenovirus
Prior treatment with a group B adenovirus
Cannot have received: anti-cancer therapy
Exception: within 28 days or 5 half-lives, whichever is longer, prior to first dose of THEO-260
Prior anti-cancer treatment with 28 days or 5 half-lives whichever is longer, prior to first dose of THEO-260
Cannot have received: investigational medicinal product
Exception: within 5 half-lives prior to first dose of THEO-260
Currently enrolled in a clinical trial of an IMP or used any IMP with 5 half-live, prior to first dose of THEO-260
Cannot have received: radiation therapy
Exception: within 2 weeks of first dose of THEO-260
Radiation therapy with 2 weeks of first dose of THEO-260 and is scheduled to have radiation therapy during participation of trial. Short courses of palliative radiation therapy should be discussed with the Medical Monitor and Sponsor.
Lab requirements
Blood counts
Adequate haematological function (parameters apply)
Kidney function
Adequate organ function (parameters apply)
Liver function
Adequate organ function (parameters apply)
Adequate haematological and organ function (parameters apply)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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