Testing THEO-260 for treating ovarian cancer

A Phase I/IIa, Open-label, Dose Finding, Safety, Tolerability and Exploratory Trial of THEO-260 in Patients With High Grade Serous or Endometrioid Ovarian Cancer

This study is testing a new treatment called THEO-260 to see if it can help women with advanced ovarian cancer feel better and improve their health.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 44 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: Theolytics Limited (Industry-sponsored)
• Drugs / interventions: Radiation
• Locations: 4 sites (Madrid and 3 other locations)
• Trial ID: NCT06618235 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the safety and efficacy of THEO-260 in adult females diagnosed with advanced ovarian cancer. It consists of two parts: the first part focuses on determining the appropriate dosage of THEO-260, while the second part involves administering the recommended dose to a larger group of participants to further assess its safety and treatment potential. Participants will receive six doses of THEO-260 over two weeks, followed by regular clinic visits for monitoring. The trial seeks to gather data on any medical issues arising from the treatment and its effectiveness against ovarian cancer.

Who should consider this trial

Good fit: Ideal candidates include adult females with advanced high grade serous or endometrioid ovarian cancer who meet specific eligibility criteria.

Not a fit: Patients with non-advanced ovarian cancer or those who do not meet the inclusion criteria may not benefit from this trial.

Why it matters

Potential benefit: If successful, this trial could provide a new treatment option for patients with ovarian cancer.

How similar studies have performed: Other studies have shown promise in targeting ovarian cancer with novel therapies, but the specific approach of THEO-260 is relatively novel.

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 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.

Where this trial is running

Madrid and 3 other locations

• Centro Integral Oncológico Clara Campal (CIOCC) Hospital — Madrid, Spain (Recruiting)
• The Beatson West of Scotland Cancer Centre — Glasgow, Scotland, United Kingdom (Recruiting)
• Imperial College Healthcare NHS Trust, Hammersmith Hospital — London, United Kingdom (Recruiting)
• Oxford University Hospitals NHS Foundation Trust, Churchill Hospital — Oxford, United Kingdom (Recruiting)

Study contacts

• Study coordinator: Clinical Trials

Conditions Ovarian Cancer