Trial of THEO-260 (Administered Via Intraperitoneal Route) in Ovarian Cancer Patients
Purpose
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.
Condition
- Ovarian Cancer
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- Female
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Phase 1
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental THEO-260 |
|
Recruiting Locations
MD Anderson Cancer Center
Houston, Texas 77030
Houston, Texas 77030
More Details
- Status
- Recruiting
- Sponsor
- Theolytics Limited