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THEO-260 for Advanced Ovarian Cancer

This study is testing a new treatment called THEO-260 for people with advanced ovarian cancer. THEO-260 is an oncolytic virus, which is a type of virus that can infect and kill cancer cells. Researchers want to find a safe and effective dose of THEO-260, which will be given directly into the abdomen (intraperitoneal route). You might be able to join if you are a woman aged 18 or older with a confirmed diagnosis of advanced high-grade serous or endometrioid ovarian, fallopian tube, or primary peritoneal cancer that has not responded well to platinum-based chemotherapy (platinum-resistant or refractory disease). The main goals are to see how safe THEO-260 is and to find the best dose for future studies. The current status of this study is unclear.

Study design
This study is testing different doses of THEO-260 in a small group of 18 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Safety will be measured until 28 days after the first dose. The recommended dose will be estimated 18 months after the study starts.

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NCT07211659

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Theolytics Limited
~18 participants
Updated 2026-04-22 on ClinicalTrials.gov
What's tested:THEO-260

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety and tolerability of THEO-260
Measured over Until Day 28 after first dose
+1 more outcome measured

Conditions

Ovarian Cancer

Explore related trials

Fallopian Tube CarcinomaMalignant Ovarian NeoplasmPrimary Peritoneal CancerSolid Neoplasm

Where it's being run

1 sites across 1 states
Texas1

Study leadership

  • Clinical Trials · STUDY_DIRECTOR · Theolytics Ltd

Who to contact

Clinical Trials
[email protected]
+441865607020
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.

Exclusion

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.
Uncontrolled pleural effusion or pericardial effusion requiring recurrent drainage procedures (as defined as once monthly or more frequently).
Prior pneumonitis or history of interstitial lung disease.
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.
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.
Active infection requiring IV antibiotics within 2 weeks prior to first dose of THEO-260, or long-term oral therapy for systemic 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.
Known alcohol consumption in excess of 2 units per day.
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.
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

What this trial measures

  • Safety and tolerability of THEO-260Until Day 28 after first dose

    Assessment of DLTs and AEs during treatment and follow-up using NCI CTCAE v5.0 or ASCO (for pneumonitis only) or ASTCT (for CRS only), plus Laboratory parameters and clinical safety assessments.

  • Establish recommended Phase 2 dose (RP2D) for THEO-260Estimated at 18 months after start of enrolment

    Determination of RP2D will be based on the totality of safety, PK and preliminary efficacy data