Phase Ib study investigating whether liposome BLP25 mucin-1 (MUC1) peptide-specific immunotherapy (L-BLP25) administered as weekly subcutaneous doses over 8 weeks following a single dose of intravenous cyclophosphamide (CPA) induces a reproducible cytokine pattern measured in the serum of unresected Stage III non-small cell lung cancer (NSCLC) subjects after first-line chemo-radiation therapy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Eight consecutive weekly subcutaneous administration with reconstituted L-BLP25 (containing 806 microgram of BLP25 lipopeptide) followed by administrations at 6-week intervals, commencing at Week 14, until disease progression is documented.
A single intravenous infusion of 300 milligram per square meter (to a maximum of 600 milligram) of CPA will be given three days before the first L-BLP25 administration.
Immune response defined as change from baseline in serum cytokine levels after L-BLP25 administration at Week 1, 4 and 8
Time frame: Pre-dose (Day -3) up to 24 hours after L-BLP25 administration at Week 1, 4 and 8
Evaluation of a cellular immune response following treatment with L-BLP25
Time frame: Pre-dose (Day -3) and at 24 hours after L-BLP25 administration at Week 4 and 8
Change from baseline in alternative immune or inflammatory serum soluble immune mediators such as interferon alpha (IFNα), transforming growth factor beta (TGFβ), or C-reactive protein (CRP) at 6, 12, and 24 hours after L-BLP25 administration.
Time frame: Pre-dose (Day -3) up to 24 hours after L-BLP25 administration at Week 1, 4 and 8
Number of subjects with adverse events (AEs)
Time frame: Up to 6 weeks after the last dose of L-BLP25
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.