THEO-260 given into the abdomen (intraperitoneal) for advanced ovarian cancer

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

This study will test a new virus-based therapy, THEO-260, delivered into the abdomen to see if it is safe and shows signs of tumor control in people with advanced platinum-resistant or -refractory ovarian cancer.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: Theolytics Limited (Industry-sponsored)
• Drugs / interventions: Radiation
• Locations: 1 site (Houston, Texas)
• Trial ID: NCT07211659 on ClinicalTrials.gov

What this trial studies

This is a Phase 1, dose-escalation trial of THEO-260, an oncolytic virus, administered via the intraperitoneal route to patients with advanced high-grade serous or endometrioid ovarian, fallopian tube, or primary peritoneal cancer. The primary focus is to identify a safe and tolerable dose while monitoring for preliminary anti-tumor activity using RECIST v1.1 measurable disease criteria. Eligible patients are platinum-resistant or platinum-refractory and must have ECOG performance status 0–1 and a life expectancy greater than six months. The trial excludes recent anticancer or investigational treatments, prior group B adenovirus exposure, recent radiation, or recent bowel obstruction, and is conducted at MD Anderson Cancer Center.

Who should consider this trial

Good fit: Adults with confirmed advanced high-grade serous or endometrioid ovarian, fallopian tube, or primary peritoneal cancer that is platinum-resistant or -refractory, with ECOG 0–1, measurable disease, life expectancy >6 months, and no recent bowel obstruction or recent investigational/anti-cancer therapy are ideal candidates.

Not a fit: Patients with poor performance status, active or recent bowel obstruction, recent radiation or investigational therapy, prior group B adenovirus exposure, or less-advanced/platinum-sensitive disease are unlikely to be eligible or benefit from this trial.

Why it matters

Potential benefit: If successful, THEO-260 could provide a new local virotherapy option that targets tumors in the peritoneal cavity and may control disease with limited systemic toxicity.

How similar studies have performed: Early-phase trials of other oncolytic viruses have demonstrated acceptable safety and occasional tumor responses in various cancers, but intraperitoneal delivery for ovarian cancer and THEO-260 specifically are novel and still early-stage.

Eligibility criteria

* 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.

Exclusion Criteria:

* 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

Where this trial is running

Houston, Texas

• MD Anderson Cancer Center — Houston, Texas, United States (Recruiting)

Study contacts

• Study coordinator: Clinical Trials

Conditions Ovarian Cancer; Ovarian cancer; Oncolytic virus; Intraperitoneal administration; Dose escalation