临床试验/NCT06618235

NCT06618235招募中1 期

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

Theolytics Limited7 个研究点分布在 2 个国家目标入组 44 人开始时间: 2024年9月24日最近更新: 2026年4月14日

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: 44
试验地点: 7
主要终点: Safety and tolerability of THEO-260 [Part A]

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验相关资讯

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 intravenously 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

•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
•Measurable disease as per RECIST V1.1.

排除标准

•Prior anti-cancer treatment within 28 days or 5 half-lives, prior to first dose of THEO-
•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-
•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-
•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-
•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-
•Received any licensed or investigational vaccines within 28 days prior to first dose of THEO-260.

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 [Part A]

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 [Part A]

时间窗: Estimated at 2 years

Determination of RP2D will be based on the totality of safety, PK and preliminary efficacy data

Evaluate preliminary efficacy of THEO-260 [Part B]

时间窗: Estimated at 16 weeks

Determine tumour response by RECIST v1.1 and iRECIST and changes in CA-125.

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 Part A of trial, estimated at 18 months after start of enrolment

The totality of safety and efficacy data collected will be used to assess RP2D.

Evaluate preliminary efficacy of THEO-260

时间窗: Until end of trial, estimated at 3 years after start of enrolment

The response to RP2D dose of THEO-260 will be assessed by Overall Response Rate (ORR) determined by tumour imaging according to RECIST v1.1.

次要结局

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 3 years after start of enrolment)
Evaluate preliminary efficacy of THEO-260 - CA125(Until end of trial, estimated at 3 years after start of enrolment)
Pharmacokinetics (PK) 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)
Preliminary efficacy of THEO-260 [Part A](Estimated at 16 weeks)
Safety and tolerability of THEO-260 [Part B](Until end of trial, estimated at 1 year after start of enrolment)

研究者

发起方

Theolytics Limited

申办方类型

Industry

责任方

Sponsor

研究点 (7)

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