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

Theolytics Limited

Status and phase

Enrolling

Phase 1

Conditions

Ovarian Cancer

Treatments

Biological: THEO-260

Study type

Interventional

Funder types

Industry

Identifiers

NCT07211659

THEO-260-002

Details and patient eligibility

About

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.

Enrollment

18 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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