NCT07211659RecruitingPhase 1

Trial of THEO-260 (Administered Via Intraperitoneal Route) in Ovarian Cancer Patients

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

Source: ClinicalTrials.gov · Last updated 22 Apr 2026

Brief summary (registry, in English)

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 by the intraperitoneal route to identify a dose that is safe, well tolerated, and exhibits preliminary evidence of anti tumour activity.

Status (registry): Recruiting
Phase (registry): Phase 1
Study type: Interventional
Enrollment: 18 (estimated)
First submitted: 1 Oct 2025
Start date: 13 Feb 2026
Primary completion date: 30 Sept 2027
Lead sponsor: Theolytics Limited
Diseases: Ovarian cancer
NCT number: NCT07211659

What you commit to

Study type: Interventional · Phase 1
Planned participants: 18
From 13 Feb 2026 to the primary completion date, 30 Sept 2027
1 site in 1 country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

Prior anti-cancer treatment or Investigational Product within 28 days or 5 half-lives, prior to first dose of THEO-260.
Prior treatment with a group B adenovirus.
Radiation therapy within 4 weeks of first dose of THEO-260
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.
Prior pneumonitis or history of interstitial lung disease.
Active infection requiring IV antibiotics within 2 weeks prior to first dose of THEO-260, or long-term oral therapy for systemic infection.
Arterial oxygen saturation \<92% on room air prior to first dose of THEO-260.
Received any licensed or investigational vaccines within 30 days prior to Day 1

Other illness

Patients with active hepatitis infection or hepatitis C. Patients with past hepatitis B virus (HBV) infection or resolved HBV infection are eligible.
Active infection with tuberculosis.
Active infection with severe acute respiratory syndrome coronavirus 2 (SARS-Cov-2).
Patients with active human immunodeficiency virus (HIV) infection or known history of HIV infection.
Known contra-indications or hypersensitivity to the excipients of THEO-260.
Active autoimmune disease that has required systemic treatment in the past 2 years.
Known heart failure New York Heart Association (NYHA) Class 2-4.
Known contra-indications or hypersensitivity to acetominophen.

Lab values

Confirmed QTcF ≥470 ms on screening 12-lead ECG or history of Torsades de Pointes or history of congenital long QT syndrome.
Concomitant medications that prolong the QTc interval and/or increase the risk for Torsades de Pointes.
Left ventricular ejection fraction (LVEF) \<45%, unstable angina, serious uncontrolled cardiac arrhythmia, a myocardial infarction within 6 months prior to trial enrolment or a history of myocarditis.

Other

Uncontrolled pleural effusion or pericardial effusion requiring recurrent drainage procedures (as defined as once monthly or more frequently).
Known alcohol consumption in excess of 2 units per day.

Criteria the registry did not label

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 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.
Life expectancy of \> 6 months.
ECOG performance status of 0 or 1.
Measurable disease as per RECIST V1.1.
No clinical history of bowel obstruction in past 3 months or no clinical signs or symptoms of bowel obstruction.

Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Site	City	Country	Site status
MD Anderson Cancer Center Coordinator of this site? Confirm its status	Houston	United States	Recruiting

This page is information, not medical advice. Discuss any trial with your doctor.