Trial of THEO-260 in Ovarian Cancer Patients

Summary

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 intravenously to identify a dose that is safe, well tolerated, and exhibits preliminary evidence of anti tumour activity.

Eligibility

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 disease (radiological recurrence/ progression with 6 months of prior platinum treatment), primary platinum-refractory disease (recurrence/ progression during first line platinum treatment) and patients who are intolerant to or have no available SOC or SOC unacceptable/ unsuitable in the view of the Investigator.
* Life expectancy of \> 3 months.
* ECOG performance status of 0 or 1.
* Measurable disease as per RECIST V1.1.

Exclusion Criteria:

* Prior anti-cancer treatment within 28 days or 5 half-lives, prior to first dose of THEO-260.
* Prior treatment with a group B adenovirus.
* Currently enrolled in a clinical trial of an IMP or used any IMP with 5 half-live, prior to first dose of THEO-260.
* Radiation therapy within 2 weeks of first dose of THEO-260 and is scheduled to have radiation therapy during participation of trial.
* 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.
* 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 the IMP.
* Viral infection during the 2 weeks prior to first dose of THEO-260.
* Active autoimmune disease that has required systemic treatment in the past 2 years.
* Known risk of renal injury, including those with a past history of acute or sub-acute renal disease.
* Known heart failure New York Heart Association (NYHA) Class 2-4.
* Known contra-indications or hypersensitivity to the AxMP, paracetamol.
* Known alcohol consumption in excess of 2 units per day.
* Left ventricular ejection fraction (LVEF) \<50%, 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 28 days prior to first dose of THEO-260.

Conditions2

Interventions1

Related trials

• Trial of THEO-260 (Administered Via Intraperitoneal Route) in Ovarian Cancer Patients — Theolytics Limited

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