To determine the tolerability, safety, end-organ toxicity and maximum tolerated dose of AS1409 in single and repeated doses.
* To determine the tolerability, safety, end-organ toxicity and maximum tolerated dose (MTD) of AS1409 in single and repeated doses. * To determine biological responses to AS1409, including interferon-γ and IP-10 circulating concentrations. * To determine preliminary pharmacokinetics of AS1409. * To determine the immunogenicity of AS1409 * To explore the anti-tumour activity of AS1409.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
13
Study drug
Auckland Medical School
Auckland, New Zealand
Waikato DHB
Hamilton, New Zealand
Guys Hospital
London, United Kingdom
Charing Cross Hospital
London, United Kingdom
Tumor assessment
Time frame: 6 weeks, response confirmed at 4 weeks
Biomarkers (interferon-γ and IP-10 Interferon)
Time frame: Various timepoints cycles 1-6, pre- and post-dose; then 1,4 and 12 weeks post last dose
Adverse event monitoring
Time frame: Various timepoints cycles 1-6, pre- and post-dose; then 1,4 and 12 weeks post last dose
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