澳洲新药CAVATAK联合K药肺癌一期临床试验
Viralytics’ lead investigational product, CAVATAK®, is a proprietary formulation of an oncolytic common cold virus that has demonstrated anti-tumour activity, along with a promising safety profile, in a Phase 2 clinical trial.CAVATAK, or Coxsackievirus (CVA21) has the potential to directly target, infect, multiply within, and destroy a wide range of cancer cells, both at the tumour site and throughout the body.CAVATAK acts by seeking out and attaching itself to a protein that is highly expressed on the surface of many cancer cells (ICAM-1). Once attached to this protein, the virus is then able to insert itself into the cancer cell, replicate, and burst the cancer cell apart, a process known as lysis. Thousands of viral progeny then can spread and replicate this cycle of destruction. During the CAVATAK process, tumour cell fragments are released, which can potentially activate the body’s own immune system by identifying the cancerous tumour cells as foreign.
CAVATAK is currently being evaluated in Phase 1 and 2 clinical trials, both as an intratumoural and intravenous agent, in melanoma, prostate, lung and bladder cancers.
Clinical Trials – Phase 1 in NSCLC
Status – in Start-up
A site-sponsored Phase Ib open-label trial to investigate the use of intravenous CAVATAK® in combination with pembrolizumab (KEYTRUDA™) for the treatment of patients with advanced Non Small Cell Lung Cancer (NSCLC) is in start-up at the Olivia Newton-John Cancer Research Institute (ONJCRI) in Melbourne, Australia.
The trial is designed to assess the safety and tolerability of the CAVATAK/KEYTRUDA combination therapy and will be conducted in two parts: the first part will assess the safety of three ascending dose levels of intravenously-delivered CAVATAK in combination with a fixed dose of pembrolizumab. Once a safe dose of CAVATAK has been determined, the second part will enroll additional subjects to further evaluate safety and assess efficacy by overall response and changes in the tumor microenvironment. The study may enrol up to 30 patients.
For information about this trial, please visit the Clinical Trial website at clinicaltrials.gov, Identifier NCT02824965. viralytics铅研究产品，cavatak®，是一种溶瘤感冒病毒显示了抗肿瘤活性的专有配方，以及一个很好的安全性，在一项2期临床试验。cavatak，或柯萨奇病毒（cva21）有直接的目标，潜在的感染、繁殖内，破坏范围广泛的肿瘤细胞，在肿瘤部位和整个身体。
cavatak行为通过寻找和依附于一种蛋白质，在许多肿瘤细胞表面高表达（ICAM-1）。一旦附着在这种蛋白质上，病毒便能将自身插入癌细胞中，复制并破坏癌细胞，这一过程称为裂解。数以千计的病毒后代可以传播和复制这一毁灭循环。的cavatak过程中，肿瘤细胞碎片被释放，它能通过识别肿瘤细胞外激活人体自身的免疫系统。
cavatak目前在阶段1和2的临床试验进行评估，同时作为一个内和静脉注射剂，在黑色素瘤、前列腺癌、肺癌和膀胱癌。
临床试验-第1阶段非小细胞肺癌
状态-启动
一个网站主办一期开放标签试验探讨静脉cavatak®结合使用pembrolizumab（Keytruda™）用于治疗晚期非小细胞肺癌（NSCLC）患者在启动在奥利维亚牛顿癌症研究所（onjcri）在墨尔本，澳大利亚。
该试验的目的是评估安全性和cavatak / Keytruda的联合治疗，将两部分进行耐受性：第一部分将探讨三升与固定剂量组合cavatak pembrolizumab静脉给予剂量的安全性。一旦安全剂量的cavatak已经确定，第二部分将招募更多的人进一步评估安全性和评估的整体反应和肿瘤微环境中的变化效果。这项研究可招收30名病人。
有关这项试验的信息，请访问在临床试验的临床试验网站，nct02824965标识符。
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