Any grade TEAEs reported by ≥20% of patients (safety analysis set)
| TEAE, n (%) . | Dose, μg/kg . | |||||||
|---|---|---|---|---|---|---|---|---|
| Q3W . | QW . | Total (N = 35) . | ||||||
| 15 (n = 5) . | 30 (n = 7) . | 60 (n = 3) . | 90 (n = 4) . | 120 (n = 5) . | 150 (n = 6) . | 50 (n = 5) . | ||
| Any | 5 (100) | 7 (100) | 3 (100) | 4 (100) | 5 (100) | 6 (100) | 5 (100) | 35 (100) |
| Nausea | 1 (20.0) | 2 (28.6) | 1 (33.3) | 2 (50.0) | 3 (60.0) | 5 (83.3) | 1 (20.0) | 15 (42.9) |
| Febrile neutropenia | 0 (0) | 1 (14.3) | 1 (33.3) | 2 (50.0) | 3 (60.0) | 4 (66.7) | 2 (40.0) | 13 (37.1) |
| AST increased | 0 (0) | 0 (0) | 2 (66.7) | 2 (50.0) | 2 (40.0) | 4 (66.7) | 1 (20.0) | 11 (31.4) |
| GGT increased | 1 (20.0) | 0 (0) | 0 (0) | 2 (50.0) | 3 (60.0) | 3 (50.0) | 1 (20.0) | 10 (28.6) |
| Alanine aminotransferase increased | 0 (0) | 0 (0) | 1 (33.3) | 2 (50.0) | 2 (40.0) | 2 (33.3) | 2 (40.0) | 9 (25.7) |
| Blood alkaline phosphatase increased | 0 (0) | 0 (0) | 2 (66.7) | 1 (25.0) | 1 (20.0) | 3 (50.0) | 2 (40.0) | 9 (25.7) |
| Fatigue | 0 (0) | 3 (42.9) | 1 (33.3) | 3 (75.0) | 2 (40.0) | 0 (0) | 0 (0) | 9 (25.7) |
| Headache | 1 (20.0) | 2 (28.6) | 1 (33.3) | 0 (0) | 2 (40.0) | 2 (33.3) | 1 (20.0) | 9 (25.7) |
| Rash maculopapular | 0 (0) | 1 (14.3) | 1 (33.3) | 1 (25.0) | 2 (40.0) | 2 (33.3) | 2 (40.0) | 9 (25.7) |
| Vomiting | 0 (0) | 1 (14.3) | 0 (0) | 1 (25.0) | 3 (60.0) | 3 (50.0) | 1 (20.0) | 9 (25.7) |
| Abdominal pain | 0 (0) | 1 (14.3) | 1 (33.3) | 1 (25.0) | 0 (0) | 3 (50.0) | 2 (40.0) | 8 (22.9) |
| Dizziness | 0 (0) | 0 (0) | 1 (33.3) | 1 (25.0) | 2 (40.0) | 2 (33.3) | 2 (40.0) | 8 (22.9) |
| Diarrhea | 1 (20.0) | 1 (14.3) | 1 (33.3) | 2 (50.0) | 0 (0) | 1 (16.7) | 1 (20.0) | 7 (20.0) |
| Dyspnea | 0 (0) | 1 (14.3) | 1 (33.3) | 3 (75.0) | 0 (0) | 1 (16.7) | 1 (20.0) | 7 (20.0) |
| TEAE, n (%) . | Dose, μg/kg . | |||||||
|---|---|---|---|---|---|---|---|---|
| Q3W . | QW . | Total (N = 35) . | ||||||
| 15 (n = 5) . | 30 (n = 7) . | 60 (n = 3) . | 90 (n = 4) . | 120 (n = 5) . | 150 (n = 6) . | 50 (n = 5) . | ||
| Any | 5 (100) | 7 (100) | 3 (100) | 4 (100) | 5 (100) | 6 (100) | 5 (100) | 35 (100) |
| Nausea | 1 (20.0) | 2 (28.6) | 1 (33.3) | 2 (50.0) | 3 (60.0) | 5 (83.3) | 1 (20.0) | 15 (42.9) |
| Febrile neutropenia | 0 (0) | 1 (14.3) | 1 (33.3) | 2 (50.0) | 3 (60.0) | 4 (66.7) | 2 (40.0) | 13 (37.1) |
| AST increased | 0 (0) | 0 (0) | 2 (66.7) | 2 (50.0) | 2 (40.0) | 4 (66.7) | 1 (20.0) | 11 (31.4) |
| GGT increased | 1 (20.0) | 0 (0) | 0 (0) | 2 (50.0) | 3 (60.0) | 3 (50.0) | 1 (20.0) | 10 (28.6) |
| Alanine aminotransferase increased | 0 (0) | 0 (0) | 1 (33.3) | 2 (50.0) | 2 (40.0) | 2 (33.3) | 2 (40.0) | 9 (25.7) |
| Blood alkaline phosphatase increased | 0 (0) | 0 (0) | 2 (66.7) | 1 (25.0) | 1 (20.0) | 3 (50.0) | 2 (40.0) | 9 (25.7) |
| Fatigue | 0 (0) | 3 (42.9) | 1 (33.3) | 3 (75.0) | 2 (40.0) | 0 (0) | 0 (0) | 9 (25.7) |
| Headache | 1 (20.0) | 2 (28.6) | 1 (33.3) | 0 (0) | 2 (40.0) | 2 (33.3) | 1 (20.0) | 9 (25.7) |
| Rash maculopapular | 0 (0) | 1 (14.3) | 1 (33.3) | 1 (25.0) | 2 (40.0) | 2 (33.3) | 2 (40.0) | 9 (25.7) |
| Vomiting | 0 (0) | 1 (14.3) | 0 (0) | 1 (25.0) | 3 (60.0) | 3 (50.0) | 1 (20.0) | 9 (25.7) |
| Abdominal pain | 0 (0) | 1 (14.3) | 1 (33.3) | 1 (25.0) | 0 (0) | 3 (50.0) | 2 (40.0) | 8 (22.9) |
| Dizziness | 0 (0) | 0 (0) | 1 (33.3) | 1 (25.0) | 2 (40.0) | 2 (33.3) | 2 (40.0) | 8 (22.9) |
| Diarrhea | 1 (20.0) | 1 (14.3) | 1 (33.3) | 2 (50.0) | 0 (0) | 1 (16.7) | 1 (20.0) | 7 (20.0) |
| Dyspnea | 0 (0) | 1 (14.3) | 1 (33.3) | 3 (75.0) | 0 (0) | 1 (16.7) | 1 (20.0) | 7 (20.0) |
AST, aspartate aminotransferase; GGT, γ-glutamyl transferase.