VLA009 Systemic Treatment of Resistant Metastatic Disease (STORM)
Research type
Research Study
Full title
A Phase I, Dose-Finding and Signal-Seeking Study of the Safety and Efficacy of Intravenous CAVATAK (Coxsackievirus A21, CVA21) Alone and in Combination with Cytotoxic Therapy in Patients with Late Stage Solid Tumours (NSCLC, Castrate-Resistant Prostate Cancer, Melanoma and Bladder Cancer)
IRAS ID
137956
Contact name
Hardev Pandha
Contact email
Sponsor organisation
Viralytics Ltd
Eudract number
2012-005256-42
ISRCTN Number
N/A
Research summary
This dose finding and signal-seeking study will assess the safety and efficacy of multi-dose intravenous CAVATAK™ (CVA21) in patients with late-stage solid tumors (Non-Small Cell Lung Cancer, Castrate-Resistant Prostate Cancer, Melanoma and Bladder Cancer), alone and in combination with cytotoxic therapy. The study will be conducted at 3 hospital sites in the United Kingdom involving about 45 people with advanced solid tumours.
The investigational product, Coxsackievirus A21 (CVA21; CAVATAK™), is a live oncolytic virus preparation derived from the non-genetically altered prototype Kuykendall strain of Coxsackievirus A21. The Sponsor, Viralytics Ltd., is evaluating the safety and efficacy of CVA21 in the treatment of advanced solid tumours and other malignancies where intercellular adhesion molecule (ICAM-1) and decay accelerating factor (DAF) receptor expression occurs.
CVA21 is a naturally occurring virus that is frequently present in the community as a cause of the common cold. Previous experience with studies carried out in the laboratory and in laboratory animals show that CVA21 can destroy some types of cancer cells, including melanoma, breast and prostatic cancer cells, with little or no effect on normal cells. It is supposed that intravenous administration of CVA21 may be a better route to reach inaccessible tumour sites than injection. As such, this trial will explore the ability of CVA21 to target tumours by intravenous administration.
Part A of this study will investigate increasing dose levels of CVA21 with the aim of identifying a tolerable dose and schedule for intravenously administered CVA21. In addition it will determine if CVA21 given intravenously is capable of tracking malignant tumours and replicating in the tracked tumour sites.
In Part B, the study will assess the safety and efficacy of intravenous CVA21 and chemotherapy in solid tumours. It will also aim to identify a tolerable dose and schedule for intravenously administered CVA21 in combination with chemotherapy.REC name
North East - York Research Ethics Committee
REC reference
13/NE/0323
Date of REC Opinion
29 Nov 2013
REC opinion
Further Information Favourable Opinion