NCT04097002进行中（未招募）1 期
A Phase I/IIa Study Evaluating the Safety and Tolerability of Intratumoral Administration of ORCA-010 in Treatment-Naïve Patients With Localized Prostate Cancer.
Orca Therapeutics B.V.10 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2019年11月12日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 24
- 试验地点
- 10
- 主要终点
- Safety profile of ORCA-010
研究概览
简要总结
This open label, dose escalating study is a phase I/IIa first in man study designed to evaluate the safety and tolerability of intratumoral administration of a novel oncolytic adenovirus (ORCA-010) in treating diagnosed treatment naïve Patients with localized prostate cancer.
详细描述
The study is divided into two parts. In Part A of the study, cohorts of subjects will be administered escalating doses of ORCA-010, using the 3+3 design. When the Maximum Tolerated Dose has been determined in Part A, a group of 12 new subjects will be treated in Part B of the study at this dose, with two administrations separated by a 2-week interval.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed adenocarcinoma of the prostate, which is localized to the prostate ( within 24 months of screening)
- •Absence of lymph node, bone or other metastases as determined by MRI and CT scan, Bone Scan or nano-MRI (≤3 months prior to first administration)
- •Men between 18 and 75 years inclusive
- •ECOG status 0 or 1
- •Ability to understand and willingness to sign informed consent
- •Adequate liver, renal and bone marrow function: AST & ALT < 2.5 x ULN, total bilirubin < 1.5 x ULN, Alkaline phosphatase < 3 x ULN, Serum creatinine < 1.5 x ULN, Haemoglobin > 9.0 g/dL (5.59 mmol/L), Platelet count > 100x10*9/L, Neutrophils > 1.5x10*9/L, INR < 1.5xULN
- •eGFR ≥ 30 mL/min, using the Cockcroft - Gault Equation: Creatinine Clearance = [{(140 - age in years) x (weight in kg)} x 1.23] /serum Creatinine in Mmol/L
排除标准
- •Tumor not accessible for injection
- •Prior treatment of prostate cancer with radiation therapy or brachytherapy
- •Prior use of chemotherapy/hormone therapy for treatment of cancer
- •Target tumor adherent to a major vascular structure
- •Participation in any investigational drug study within the last 12 months prior to first administration of ORCA-010
- •Clinically significant active infection (viral or bacterial)
- •Known immunosuppressive diseases (e.g. HIV, Hepatitis B and C)
- •History of any other oncological malignancy, excluding basal cell carcinoma of the skin, in the past 5 years
- •Not willing to refrain from sexual activities or use a double barrier contraceptive device (condom with foam or vaginal suppository, diaphragm with spermicide) after administration of ORCA-010 and until 42 days after the last ORCA-010 administration
- •Severe obesity defined as Body Mass Index (BMI) > 30 kg/m2
- •Positive for adenovirus in throat swap or serum as determined by PCR at screening
- •Recent (within 3 months prior to enrolment in the study) history of alcohol abuse or other substances such as barbiturates, cannabinoids and amphetamines or a positive urine screen for drugs of abuse
- •Use of medication known to have immunosuppressive effects, except topical/inhaled steroids under 10 mg/day prednisolone equivalent (See Appendix 7)
- •Use of systemic antiviral medication within 3 months prior to enrolment in the study
- •Use of any anti-coagulants/blood thinner except for ASA 81mg
- •Any condition that in the opinion of the Investigator could interfere with the conduct of the study
- •For Part B only: Subjects enrolled in Part A of the study
结局指标
主要结局
Safety profile of ORCA-010
时间窗: 365 days
To evaluate safety and tolerability of intratumoral administration of ORCA-010 according to CTCAE V5.0. The primary endpoint of this study is to assess Dose Limiting Toxicities (DLTs) and the Maximum Tolerated Dose (MTD) for ORCA-010 to determine the final safety dose of administration for Phase IIa/Part B.
次要结局
- Biological activity of ORCA-010(365 days)
- Shedding of ORCA-010(365 days)
- Antitumor immune responses(365 days)
研究者
研究点 (10)
Loading locations...
相似试验
进行中（未招募）
1 期
A Study to Evaluate the Safety, Pharmacokinetics and Preliminary Anti-Tumor Activity of Englumafusp Alfa in Combination With Obinutuzumab and in Combination With Glofitamab Following a Pre-Treatment Dose of Obinutuzumab in Participants With Relapsed/Refractory B-Cell Non-Hodgkin's LymphomaLymphoma, Non-HodgkinNCT04077723Hoffmann-La Roche498
已完成
1 期
Dose-escalation Study of Intravenous Liposomal Vinorelbine Tartrate Injection in Patients With Advanced MalignancyCancerNCT02925000Taiwan Liposome Company46
招募中
1 期
H002 in Patients With EGFR Mutation Locally Advanced or Metastatic NSCLCNon-small Cell Lung CancerNCT05552781RedCloud Bio76
招募中
1 期
Phase I/IIa Study of H002 in NSCLC With Active EGFR MutationNon-small Cell Lung CancerNCT05519293RedCloud Bio76
已完成
1 期
A Phase I, Open-label, Study of Pazopanib in Combination With Gemcitabine and Gemcitabine Plus Cisplatin for Advanced Solid TumorsLung Cancer, Non-Small CellNCT00678977GlaxoSmithKline22