Most common AEs in all patients, and patients in the 1.5 and 3 mg/kg Q4W cohorts
| . | All patients (N = 106) . | 1.5 mg/kg Q4W cohorts∗ (n = 30) . | 3.0 mg/kg Q4W cohort (n= 7) . | |||
|---|---|---|---|---|---|---|
| All grades . | Grade 3 or 4 . | All grades . | Grade 3 or 4 . | All grades . | Grade 3 or 4 . | |
| Event . | n (%) . | |||||
| Thrombocytopenia | 82 (77.4) | 55 (51.9) | 22 (73.3) | 14 (46.7) | 5 (71.4) | 4 (57.1) |
| Neutropenia | 63 (59.4) | 57 (53.8) | 22 (73.3) | 20 (66.7) | 6 (85.7) | 4 (57.1) |
| Leukopenia | 58 (54.7) | 42 (39.6) | 16 (53.3) | 13 (43.3) | 4 (57.1) | 3 (42.9) |
| Anemia | 54 (50.9) | 31 (29.2) | 18 (60) | 10 (33.3) | 4 (57.1) | 3 (42.9) |
| Lymphopenia | 40 (37.7) | 29 (27.4) | 11 (36.7) | 11 (36.7) | 2 (28.6) | 2 (28.6) |
| Hyperglycemia | 35 (33) | 4 (3.8) | 7 (23.3) | 1 (3.3) | 2 (28.6) | 0 |
| Fatigue | 34 (32.1) | 2 (1.9) | 11 (36.7) | 0 | 2 (28.6) | 0 |
| Hypocalcemia | 27 (25.5) | 1 (<1) | 10 (33.3) | 0 | 1 (14.3) | 0 |
| Nausea | 19 (17.9) | 0 | 6 (20) | 0 | 2 (28.6) | 0 |
| Diarrhea | 24 (22.6) | 0 | 3 (10) | 0 | 1 (14.3) | 0 |
| Infusion-related reaction | 24 (22.6) | 2 (1.9) | 11 (36.7) | 1 (3.3) | 3 (42.9) | 0 |
| Hypoalbuminemia | 21 (19.8) | 1 (<1) | 5 (16.7) | 1 (3.3) | 1 (14.3) | 0 |
| Hyponatremia | 23 (21.7) | 9 (8.5) | 5 (16.7) | 1 (3.3) | 1 (14.3) | 0 |
| Back pain | 17 (16) | 5 (4.7) | 7 (23.3) | 1 (3.3) | 0 | 0 |
| Aspartate aminotransferase increased | 19 (17.9) | 2 (1.9) | 5 (16.7) | 0 | 2 (28.6) | 0 |
| Dyspnea | 17 (16) | 3 (2.8) | 5 (16.7) | 0 | 2 (28.6) | 0 |
| Headache | 15 (14.2) | 1 (<1) | 7 (23.3) | 1 (3.3) | 0 | 0 |
| Cough | 19 (17.9) | 0 | 8 (26.7) | 0 | 2 (28.6) | 0 |
| Hypophosphatemia | 16 (15.1) | 5 (4.7) | 8 (26.7) | 3 (10.0) | 0 | 0 |
| Pyrexia | 11 (10.4) | 1 (<1) | 5 (16.7) | 1 (3.3) | 0 | 0 |
| Chills | 3 (2.8) | 0 | 0 | 0 | 1 (14.3) | 0 |
| Pneumonia | 14 (13.2) | 11 (10.4) | 4 (13.3) | 4 (13.3) | 4 (57.1) | 2 (28.6) |
| Pruritus | 5 (4.7) | 1 (<1) | 1 (3.3) | 0 | 1 (14.3) | 0 |
| Epistaxis | 9 (8.5) | 0 | 0 | 0 | 3 (42.9) | 0 |
| Tachycardia | 3 (2.8) | 0 | 2 (6.7) | 0 | 1 (14.3) | 0 |
| Hypertension | 3 (2.8) | 2 (1.9) | 1 (3.3) | 0 | 1 (14.3) | 1 (14.3) |
| Wheezing | 2 (1.9) | 0 | 1 (3.3) | 0 | 1 (14.3) | 0 |
| . | All patients (N = 106) . | 1.5 mg/kg Q4W cohorts∗ (n = 30) . | 3.0 mg/kg Q4W cohort (n= 7) . | |||
|---|---|---|---|---|---|---|
| All grades . | Grade 3 or 4 . | All grades . | Grade 3 or 4 . | All grades . | Grade 3 or 4 . | |
| Event . | n (%) . | |||||
| Thrombocytopenia | 82 (77.4) | 55 (51.9) | 22 (73.3) | 14 (46.7) | 5 (71.4) | 4 (57.1) |
| Neutropenia | 63 (59.4) | 57 (53.8) | 22 (73.3) | 20 (66.7) | 6 (85.7) | 4 (57.1) |
| Leukopenia | 58 (54.7) | 42 (39.6) | 16 (53.3) | 13 (43.3) | 4 (57.1) | 3 (42.9) |
| Anemia | 54 (50.9) | 31 (29.2) | 18 (60) | 10 (33.3) | 4 (57.1) | 3 (42.9) |
| Lymphopenia | 40 (37.7) | 29 (27.4) | 11 (36.7) | 11 (36.7) | 2 (28.6) | 2 (28.6) |
| Hyperglycemia | 35 (33) | 4 (3.8) | 7 (23.3) | 1 (3.3) | 2 (28.6) | 0 |
| Fatigue | 34 (32.1) | 2 (1.9) | 11 (36.7) | 0 | 2 (28.6) | 0 |
| Hypocalcemia | 27 (25.5) | 1 (<1) | 10 (33.3) | 0 | 1 (14.3) | 0 |
| Nausea | 19 (17.9) | 0 | 6 (20) | 0 | 2 (28.6) | 0 |
| Diarrhea | 24 (22.6) | 0 | 3 (10) | 0 | 1 (14.3) | 0 |
| Infusion-related reaction | 24 (22.6) | 2 (1.9) | 11 (36.7) | 1 (3.3) | 3 (42.9) | 0 |
| Hypoalbuminemia | 21 (19.8) | 1 (<1) | 5 (16.7) | 1 (3.3) | 1 (14.3) | 0 |
| Hyponatremia | 23 (21.7) | 9 (8.5) | 5 (16.7) | 1 (3.3) | 1 (14.3) | 0 |
| Back pain | 17 (16) | 5 (4.7) | 7 (23.3) | 1 (3.3) | 0 | 0 |
| Aspartate aminotransferase increased | 19 (17.9) | 2 (1.9) | 5 (16.7) | 0 | 2 (28.6) | 0 |
| Dyspnea | 17 (16) | 3 (2.8) | 5 (16.7) | 0 | 2 (28.6) | 0 |
| Headache | 15 (14.2) | 1 (<1) | 7 (23.3) | 1 (3.3) | 0 | 0 |
| Cough | 19 (17.9) | 0 | 8 (26.7) | 0 | 2 (28.6) | 0 |
| Hypophosphatemia | 16 (15.1) | 5 (4.7) | 8 (26.7) | 3 (10.0) | 0 | 0 |
| Pyrexia | 11 (10.4) | 1 (<1) | 5 (16.7) | 1 (3.3) | 0 | 0 |
| Chills | 3 (2.8) | 0 | 0 | 0 | 1 (14.3) | 0 |
| Pneumonia | 14 (13.2) | 11 (10.4) | 4 (13.3) | 4 (13.3) | 4 (57.1) | 2 (28.6) |
| Pruritus | 5 (4.7) | 1 (<1) | 1 (3.3) | 0 | 1 (14.3) | 0 |
| Epistaxis | 9 (8.5) | 0 | 0 | 0 | 3 (42.9) | 0 |
| Tachycardia | 3 (2.8) | 0 | 2 (6.7) | 0 | 1 (14.3) | 0 |
| Hypertension | 3 (2.8) | 2 (1.9) | 1 (3.3) | 0 | 1 (14.3) | 1 (14.3) |
| Wheezing | 2 (1.9) | 0 | 1 (3.3) | 0 | 1 (14.3) | 0 |
The most common adverse events (AEs) were defined as those that occurred in at least 20% of patients in any column.
Includes patients in dose escalation (n = 5) and dose expansion (n = 25).