Patient | Dose level (μg/kg) | Course of therapy | Toxicities ≥ grade 1 | Dose-limiting toxicity | Neutralizing antibodies | Clinical response |
---|---|---|---|---|---|---|
N01 | 2 | According to plan | GGT grade 2 | No | No | Progression |
U01 | 2 | Stopped on day 10 | Cholestasis due to liver metastasisa | No | n.d. | n.d. |
U02 | 2 | According to plan | None | No | n.d. | Progression |
N03 | 4 | According to plan | GGT grade 2 | No | No | Stable disease |
N04 | 4 | According to plan | ALT grade 1 | No | No | Stable disease |
N05 | 4 | According to plan | Hemoglobin grade 3a | No | No | Progression |
N06 | 10 | According to plan | ALT grade 2, AST grade 1 | No | + | Progression |
N07 | 10 | According to plan | ALT/AST grade 1, GGT grade 3 | No | No | Progression |
U03 | 10 | According to plan | Fever and dyspnoeb | No | ++ | n.d.c |
N13 | 12.5 | According to plan | ALT grade 1, GGT grade 2, AP grade 1 | No | No | Progression |
N14 | 12.5 | Stopped on day 8 | ALT/AST grade 3, GGT grade 2, LDH grade 1 | Yes | n.d. | n.d. |
N15 | 12.5 | According to plan | ALT grade 2, AST grade 1, AP grade 2 | No | + | Progression |
N17 | 12.5 | According to plan | ALT/AST grade 2 | No | No | Progression |
U04 | 12.5 | According to plan | Dyspnoe | No | No | n.d.c |
U05 | 12.5 | According to plan | None | No | ++ | Stable disease |
N09 | 20 | According to plan | ALT/AST grade 2 | No | +++ | Progression |
N10 | 20 | Stopped on day 8 | ALT grade 4, AST grade 3, GGT grade 2 | Yes | n.d. | n.d. |
N12 | 20 | Stopped on day 8 | ALT grade 3, AST grade 2 | Yes | n.d. | n.d.c |