Asterias Biotherapeutics has enrolled and dosed the first subject in a Phase l clinical trial of AST-VAC2 for the treatment of non-small cell lung cancer (NSCLC) in the UK.
The first-in-human trial’s primary objective is to examine the safety and tolerability of AST-VAC2 in NSCLC, while its secondary and tertiary endpoints include evaluations of the immunogenicity of AST-VAC2 in NSCLC.
It aims to enrol up to 24 subjects into one of two cohorts, depending on the stage of their NSCLC.
The first cohort will analyse AST-VAC2 in up to 12 patients with advanced NSCLC.
Patients in this cohort who have the major histocompatibility gene, HLA-A2, will be given six weekly injections of AST-VAC2 and will be followed for safety, immune responses to telomerase and overall clinical survival.
If safety is demonstrated in the first cohort, the trial will start enrolling patients for a second cohort, which will include early stage subjects who have had a successful resection of their tumour with no evidence of metastasis.
The second cohort will enrol up to 12 patients who carry the major histocompatibility allele, HLA-A2. They will receive six weekly injections of AST-VAC2 and be followed for safety, immune responses to telomerase, overall clinical survival and time to relapse.
Survival results from both the cohorts will be compared directly to a control group who meet all of the other inclusion/exclusion criteria but do not possess the HLA-A2 gene.
Patients are expected to be followed for one year for an immune response to telomerase and for two years for the survival endpoints.
An immune pathway inhibitor has been selected to explore its combination with AST-VAC2.
The trial is being sponsored, managed and funded by Cancer Research UK.