Any-grade treatment-related AEs occurring in ≥10% of total population and all grade ≥ 3 treatment-related AEs
| Q3W (mg/kg) | Q2W (mg/kg) | QW × 2 (mg/kg) | QW × 4 (mg/kg) | Total | ||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Cohort 10.1 (n = 5) | Cohort 20.5 (n = 5) | Cohort 32.5 (n = 3) | Cohort 410 (n = 6) | Cohort 520 (n = 9) | Cohort 610 (n = 4) | Cohort 720 (n = 18) | Cohort 820 (n = 3) | Cohort 920 (n = 5) | N = 58 | |
| Any-grade treatment-related AEa | 5 (100) | 4 (80) | 3 (100) | 5 (83) | 5 (56) | 4 (100) | 15 (83) | 3 (100) | 4 (80) | 48 (83) |
| Fatigue | 0 | 1 (20) | 0 | 1 (17) | 1 (11) | 1 (25) | 7 (39) | 1 (33) | 0 | 12 (21) |
| Decreased appetite | 2 (40) | 1 (20) | 2 (67) | 1 (17) | 0 | 0 | 3 (17) | 0 | 0 | 9 (16) |
| Nausea | 1 (20) | 2 (40) | 0 | 1 (17) | 1 (11) | 1 (25) | 2 (11) | 1 (33) | 0 | 9 (16) |
| Vomiting | 2 (40) | 1 (20) | 0 | 0 | 0 | 1 (25) | 3 (17) | 1 (33) | 0 | 8 (14) |
| Anemia | 0 | 1 (20) | 0 | 0 | 1 (11) | 0 | 3 (17) | 0 | 2 (40) | 7 (12) |
| Arthralgia | 0 | 0 | 0 | 0 | 1 (11) | 0 | 3 (17) | 1 (33) | 2 (40) | 7 (12) |
| Pyrexia | 1 (20) | 1 (20) | 0 | 1 (17) | 0 | 1 (25) | 2 (11) | 0 | 1 (20) | 7 (12) |
| Asthenia | 0 | 1 (20) | 0 | 0 | 1 (11) | 0 | 4 (22) | 0 | 0 | 6 (10) |
| Pruritus | 1 (20) | 0 | 1 (33) | 0 | 1 (11) | 0 | 3 (17) | 0 | 0 | 6 (10) |
| Grade ≥ 3 treatment-related AEsa | 0 | 3 (60) | 0 | 0 | 2 (22) | 0 | 6 (33) | 0 | 1 (20) | 12 (20) |
| Anemia | 0 | 1 (20) | 0 | 0 | 1 (11) | 0 | 1 (6) | 0 | 1 (20) | 4 (7) |
| Fatigue | 0 | 1 (20) | 0 | 0 | 1 (11) | 0 | 0 | 0 | 0 | 2 (3) |
| Aspartate aminotransferase increased | 0 | 1 (20) | 0 | 0 | 0 | 0 | 1 (6) | 0 | 0 | 2 (3) |
| Asthenia | 0 | 0 | 0 | 0 | 1 (11) | 0 | 0 | 0 | 0 | 1 (2) |
| Abdominal pain | 0 | 0 | 0 | 0 | 0 | 0 | 1 (6) | 0 | 0 | 1 (2) |
| Diarrhea | 0 | 0 | 0 | 0 | 0 | 0 | 1 (6) | 0 | 0 | 1 (2) |
| Autoimmune hepatitis | 0 | 1 (20) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (2) |
| Urinary tract infection | 0 | 0 | 0 | 0 | 0 | 0 | 1 (6) | 0 | 0 | 1 (2) |
| Alanine aminotransferase increased | 0 | 1 (20) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (2) |
| Blood alkaline phosphatase increased | 0 | 1 (20) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (2) |
| Blood creatine phosphokinase increased | 0 | 0 | 0 | 0 | 0 | 0 | 1 (6) | 0 | 0 | 1 (2) |
| Lipase increased | 0 | 0 | 0 | 0 | 1 (11) | 0 | 0 | 0 | 0 | 1 (2) |
| Dehydration | 0 | 0 | 0 | 0 | 1 (11) | 0 | 0 | 0 | 0 | 1 (2) |
| Hypercalcemia | 0 | 0 | 0 | 0 | 1 (11) | 0 | 0 | 0 | 0 | 1 (2) |
| Hyperkalemia | 0 | 0 | 0 | 0 | 0 | 0 | 1 (6) | 0 | 0 | 1 (2) |
| Arthralgia | 0 | 0 | 0 | 0 | 0 | 0 | 1 (6) | 0 | 0 | 1 (2) |
| Myositis | 0 | 0 | 0 | 0 | 0 | 0 | 1 (6) | 0 | 0 | 1 (2) |
| Myasthenia gravis | 0 | 0 | 0 | 0 | 0 | 0 | 1 (6) | 0 | 0 | 1 (2) |
| Hypertension | 0 | 0 | 0 | 0 | 0 | 0 | 1 (6) | 0 | 0 | 1 (2) |
All grade ≥ 3 events were grade 3, with the exception of two grade 4 events (one event of increased blood creatine phosphokinase and one event of myositis)
Abbreviation: AE adverse event
aPatients were counted once for each category regardless of the number of events