A phase I study of IMP321 and gemcitabine as the front-line therapy in patients with advanced pancreatic adenocarcinoma Full Text
Investigational New Drugs, 08/08/2012
Wang–Gillam A et al. – IMP321 in combination with gemcitabine is a well–tolerated regimen. IMP321 did not result in any severe adverse events. No incremental activity observed for the additional IMP 321 to gemcitabine at the dose levels evaluated, likely due to sub–optimal dosing. Immunological markers suggested that higher dose levels of IMP321 are needed for future clinical studies.Methods
- Patients with advanced pancreatic adenocarcinoma were treated with gemcitabine (1,000mg/m2)(level 1), gemcitabine (1,000mg/m2) plus IMP 321 at 0.5mg (level 2) and 2.0mg (level 3), respectively.
- Safety, toxicity, and immunological markers at baseline and post treatment were assessed.
- A total of 18 patients were enrolled to the study, and 17 were evaluable for toxicity.
- None of the 6 patients who received 0.5mg IMP321 experienced IMP321-related adverse events.
- Of the 5 patients who received IMP321 at the 2mg dose level, 1 experienced rash, 1 reported hot flashes and 2 had mild pain at the injection sites.
- No severe adverse events previously attributed to IMP321 were observed.
- No significant differences were observed when comparing pre- and post-treatment levels of monocytes (CD11b+CD14+), conventional dendritic cells (CD11c+) or T cell subsets (CD4, CD8).