Incidence and severity of adverse events
| . | Part A n = 63 . | Part B RDL n = 44 . | ||
|---|---|---|---|---|
| Events . | Grade 2 n (%) . | Grade 3-4 n (%) . | Grade 2 n (%) . | Grade 3-4 n (%) . |
| Hematologic | ||||
| Anemia | 11 (17) | 8 (13)* | 21 (48) | 3 (7)* |
| Thrombocytopenia | 9 (14) | 11 (17)† | 3 (7) | 6 (14)† |
| Neutropenia | 13 (21) | 9 (14)‡ | 4 (9) | 5 (11)‡ |
| Febrile neutropenia | — | 1 (2)‡ | — | — |
| Infusion-related reaction | 12 (19)§ | — | — | — |
| Infections | 26 (42) | 11 (18) | 28 (64) | 6 (14) |
| Upper respiratory tract | 14 (22) | — | 14 (32) | — |
| Pneumonia | 3 (5) | 4 (6) | 2 (5) | 5 (11) |
| Gastrointestinal | 2 (3) | 3 (5) | 1 (2) | — |
| Urinary tract infection | 1 (2) | — | 7 (16) | 1 (2) |
| Skin infection | 4 (6) | 1 (2) | 1 (2) | — |
| Other | 2 (3)¶ | 3 (5)# | 3 (7)** | — |
| Headache | 1 (2) | — | 5 (11) | — |
| Thromboembolic event | — | 1 (2) | — | — |
| Second primary malignancy | 2 (3)†† | — | — | — |
| Fatigue | 6 (10) | 1 (2) | 3 (7) | 1 (2) |
| . | Part A n = 63 . | Part B RDL n = 44 . | ||
|---|---|---|---|---|
| Events . | Grade 2 n (%) . | Grade 3-4 n (%) . | Grade 2 n (%) . | Grade 3-4 n (%) . |
| Hematologic | ||||
| Anemia | 11 (17) | 8 (13)* | 21 (48) | 3 (7)* |
| Thrombocytopenia | 9 (14) | 11 (17)† | 3 (7) | 6 (14)† |
| Neutropenia | 13 (21) | 9 (14)‡ | 4 (9) | 5 (11)‡ |
| Febrile neutropenia | — | 1 (2)‡ | — | — |
| Infusion-related reaction | 12 (19)§ | — | — | — |
| Infections | 26 (42) | 11 (18) | 28 (64) | 6 (14) |
| Upper respiratory tract | 14 (22) | — | 14 (32) | — |
| Pneumonia | 3 (5) | 4 (6) | 2 (5) | 5 (11) |
| Gastrointestinal | 2 (3) | 3 (5) | 1 (2) | — |
| Urinary tract infection | 1 (2) | — | 7 (16) | 1 (2) |
| Skin infection | 4 (6) | 1 (2) | 1 (2) | — |
| Other | 2 (3)¶ | 3 (5)# | 3 (7)** | — |
| Headache | 1 (2) | — | 5 (11) | — |
| Thromboembolic event | — | 1 (2) | — | — |
| Second primary malignancy | 2 (3)†† | — | — | — |
| Fatigue | 6 (10) | 1 (2) | 3 (7) | 1 (2) |
Patients requiring erythrocyte transfusions: part A, n = 16 (25%); part B, n = 11 (25%).
Patients requiring platelet transfusion: part A, n = 6 (10%); part B, n = 4 (9%).
Patients requiring granulocyte colony-stimulating factor support: part A, n = 12 (19%); part B, n = 6 (14%).
Any grade infusion-related reaction: 22 patients (35%).
Eye infection and tooth infection (both n = 1).
Cytomegalovirus infection, peripherally inserted central catheter line infection and tooth infection (all n = 1).
Candida stomatitis, sinusitis, and no focus found (all n = 1).
Basal cell carcinoma and mesothelioma (both n = 1).