NCT07211659招募中1 期
A Phase I, Open-label, Dose Finding, Safety, Tolerability and Exploratory Trial of THEO-260 Administered Via an Intraperitoneal Route in Patients With High Grade Serous or Endometrioid Ovarian Cancer
Theolytics Limited1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2026年2月13日最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Safety and tolerability of THEO-260
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
- •Measurable disease as per RECIST V1.
- •No clinical history of bowel obstruction in past 3 months or no clinical signs or symptoms of bowel obstruction.
排除标准
- •Prior anti-cancer treatment or Investigational Product within 28 days or 5 half-lives, prior to first dose of THEO-
- •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-
- •Active autoimmune disease that has required systemic treatment in the past 2 years.
- •Known heart failure New York Heart Association (NYHA) Class 2-
- •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-
- •Received any licensed or investigational vaccines within 30 days prior to Day 1
研究组 & 干预措施
THEO-260
Experimental
干预措施: THEO-260 (Biological)
结局指标
主要结局
Safety and tolerability of THEO-260
时间窗: Until Day 28 after first dose
Assessment of DLTs and AEs during treatment and follow-up using NCI CTCAE v5.0 or ASCO (for pneumonitis only) or ASTCT (for CRS only), plus Laboratory parameters and clinical safety assessments.
Establish recommended Phase 2 dose (RP2D) for THEO-260
时间窗: Estimated at 18 months after start of enrolment
Determination of RP2D will be based on the totality of safety, PK and preliminary efficacy data
Safety and tolerability of THEO-260
时间窗: Until end of trial for a participant, estimated at 1 year
Safety and tolerability will be assessed by: Evaluation of DLTs and AEs during treatment and follow-up using National Cancer Institute (NCI) Common Terminology Criteria for AEs (CTCAE) v5.0 or American Society of Clinical Oncology (ASCO; for pneumonitis only) or American Society for Transplantation and Cellular Therapy (ASTCT; for cytokine release syndrome \[CRS\] only).
Establish recommended Phase 2 dose (RP2D) for THEO-260
时间窗: Until end of trial, estimated at 16 months after start of enrolment
The totality of safety and efficacy data collected will be used to assess RP2D.
次要结局
- Pharmacokinetic (PK) profile of THEO-260(Estimated at 16 weeks)
- Shedding of THEO-260(Until Day 29 after first dose)
- Systemic CRS risk after THEO-260(Until Day 29 after first dose)
- Evaluate preliminary efficacy of THEO-260(Estimated at 16 weeks)
- Pharmacokinetic (PK) profile of THEO-260(Until Day 29 after first dose)
- Shedding of THEO-260 in saliva, urine, and faeces(Until Day 29 after first dose)
- Risk of systemic cytokine release syndrome (CRS) after THEO-260(Until Day 29 after first dose)
- Evaluate preliminary efficacy of THEO-260 - RECIST(Until end of trial, estimated at 15 months after start of enrolment)
- Evaluate preliminary efficacy of THEO-260 - CA125(Until end of trial, estimated at 16 months after start of enrolment)
研究者
研究点 (1)
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相关资讯
Theolytics Secures €8 Million EU Grant to Advance Novel Oncolytic Immunotherapy for Platinum-Resistant Ovarian Cancer- Theolytics has been awarded €8 million in non-dilutive grant funding from Horizon Europe 2025 to advance its Phase 2 OCTOPOD-IV clinical trial of THEO-260 in platinum-resistant ovarian cancer.
- THEO-260 is a novel oncolytic immunotherapy designed to kill both cancer cells and cancer-associated fibroblasts while inducing immune activation in stroma-rich solid tumors.
- The competitive funding award validates the company's innovative approach to addressing significant unmet medical needs in patients with advanced ovarian cancer, whose life expectancy is typically one year or less.
- The grant will support up to 20 patients in the Phase 2a expansion study and involves major international clinical centers including institutions in Spain, Canada, and the UK.6 months agoTheolytics Advances Novel Oncolytic Immunotherapy THEO-260 in Phase I/IIa Ovarian Cancer Trial- Theolytics is presenting data from the ongoing OCTOPOD-IV Phase I/IIa trial of THEO-260, a novel oncolytic immunotherapy targeting cancer cells and cancer-associated fibroblasts in ovarian cancer patients.
- The first-in-human trial evaluates intravenous delivery of THEO-260 in patients with high-grade serous or endometrioid ovarian cancer, with recruitment ongoing at UK sites and international expansion planned.
- A second US trial (OCTOPOD-IP) investigating intraperitoneal delivery has been initiated in collaboration with MD Anderson Cancer Center, addressing the significant unmet need in platinum-resistant ovarian cancer.
- THEO-260's differentiated mechanism targets the stromal-rich tumor microenvironment, where cancer-associated fibroblasts can comprise up to 60% of tumor volume in ovarian cancer.11 months ago