Идёт набор NCT06618235

Trial of THEO-260 in Ovarian Cancer Patients

Фаза I / Фаза II С лечением Ovarian Cancer

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: THEO-260.
Кому может быть актуально: Состояния в реестре: Ovarian Cancer. Базовые параметры: от 18 лет · Женщины.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Испания, Великобритания
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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.

Вмешательства

Биопрепарат THEO-260
Oncolytic Virus

Первичные конечные точки

Safety and tolerability of THEO-260 [Part A] [Срок оценки: Until Day 28 after first dose]
Establish recommended Phase 2 dose (RP2D) for THEO-260 [Part A] [Срок оценки: Estimated at 2 years]
Evaluate preliminary efficacy of THEO-260 [Part B] [Срок оценки: Estimated at 16 weeks]

Вторичные конечные точки (5)

Pharmacokinetics (PK) of THEO-260 [Срок оценки: Estimated at 16 weeks]
Shedding of THEO-260 [Срок оценки: Until Day 29 after first dose]
Systemic CRS risk after THEO-260 [Срок оценки: Until Day 29 after first dose]
Preliminary efficacy of THEO-260 [Part A] [Срок оценки: Estimated at 16 weeks]
Safety and tolerability of THEO-260 [Part B] [Срок оценки: Until end of trial, estimated at 1 year after start of enrolment]

Критерии участия

Критерии включения

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.

Критерии исключения

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.