Trial of THEO-260 in Ovarian Cancer Patients (NCT06618235) | Clinical Trial Compass
RecruitingPhase 1/2
Trial of THEO-260 in Ovarian Cancer Patients
Spain, United Kingdom44 participantsStarted 2024-09-24
Plain-language summary
A research study evaluating a new oncolytic virus, THEO-260, in patients with advanced ovarian cancer. The trial will investigate different doses of THEO-260 administered intravenously to identify a dose that is safe, well tolerated, and exhibits preliminary evidence of anti tumour activity.
Who can participate
Age range18 Years
SexFEMALE
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Inclusion Criteria:
* 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 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.
* Life expectancy of \> 3 months.
* ECOG performance status of 0 or 1.
* Measurable disease as per RECIST V1.1.
Exclusion Criteria:
* Prior anti-cancer treatment within 28 days or 5 half-lives, prior to first dose of THEO-260.
* Prior treatment with a group B adenovirus.
* Currently enrolled in a clinical trial of an IMP or used any IMP with 5 half-live, prior to first dose of THEO-260.
* Radiation therapy within 2 weeks of first dose of THEO-260 and is scheduled to have radiation therapy during participation of trial.
* Clinical evidence of cerebral metastases or Central Nervous System (CNS) involvement including leptomeningeal disease. Patients with previous cerebral metastases must have no evidence of progression or haemorrhage after treatment.
* Uncontrolled pleural effusion or pericardial effusion requiring recurrent drainage procedures (as defined as once monthly or more frequently).
* Prior pneumonitis or history of interstitial lun…
What they're measuring
1
Safety and tolerability of THEO-260 [Part A]
Timeframe: Until Day 28 after first dose
2
Establish recommended Phase 2 dose (RP2D) for THEO-260 [Part A]
Timeframe: Estimated at 2 years
3
Evaluate preliminary efficacy of THEO-260 [Part B]