Treatment-related TEAEs (≥10% of all treated population)
| TEAEs, n (%) . | Phase 1 part . | Phase 2 part (n = 35) . | All treated (n = 72) . | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Dose escalation . | Dose expansion 1.8 mg/m2 (n = 13) . | |||||||||||
| 1.2 mg/m2 (n = 3) . | 1.6 mg/m2 (n = 12) . | 1.8 mg/m2 (n = 9) . | ||||||||||
| Any grade . | Grade ≥3 . | Any grade . | Grade ≥3 . | Any grade . | Grade ≥3 . | Any grade . | Grade ≥3 . | Any grade . | Grade ≥3 . | Any grade . | Grade ≥3 . | |
| Thrombocytopenia* | 2 (67) | 1 (33) | 4 (33) | 3 (25) | 4 (44) | 4 (44) | 4 (31) | 4 (31) | 12 (34) | 12 (34) | 26 (36) | 24 (33) |
| Neutropenia†,‡ | 1 (33) | 1 (33) | 2 (17) | 2 (17) | 5 (56) | 5 (56) | 3 (23) | 3 (23) | 9 (26) | 7 (20) | 20 (28) | 18 (25) |
| AST increased | 0 | 0 | 3 (25) | 0 | 5 (56) | 0 | 3 (23) | 0 | 8 (23) | 2 (6) | 19 (26) | 2 (3) |
| Nausea | 0 | 0 | 2 (17) | 0 | 2 (22) | 0 | 3 (23) | 0 | 8 (23) | 0 | 15 (21) | 0 |
| Vomiting | 0 | 0 | 2 (17) | 0 | 2 (22) | 1 (11) | 2 (15) | 0 | 6 (17) | 0 | 12 (17) | 1 (1) |
| Fatigue | 0 | 0 | 5 (42) | 0 | 1 (11) | 0 | 1 (8) | 0 | 4 (11) | 0 | 11 (15) | 0 |
| Febrile neutropenia | 0 | 0 | 0 | 0 | 0 | 0 | 2 (15) | 2 (15) | 9 (26) | 7 (20) | 11 (15) | 9 (13) |
| AP increased | 0 | 0 | 0 | 0 | 4 (44) | 1 (11) | 1 (8) | 0 | 5 (14) | 0 | 10 (14) | 1 (1) |
| Anemia§ | 0 | 0 | 1 (8) | 1 (8) | 2 (22) | 1 (11) | 2 (15) | 2 (15) | 5 (14) | 4 (11) | 10 (14) | 8 (11) |
| GGT increased | 1 (33) | 0 | 0 | 0 | 5 (56) | 1 (11) | 0 | 0 | 3 (9) | 0 | 9 (13) | 1 (1) |
| ALT increased | 0 | 0 | 1 (8) | 1 (8) | 1 (11) | 1 (11) | 1 (8) | 0 | 5 (14) | 0 | 8 (11) | 2 (3) |
| Pyrexia | 0 | 0 | 0 | 0 | 1 (11) | 0 | 2 (15) | 0 | 5 (14) | 0 | 8 (11) | 0 |
| Hyperbilirubinemia | 0 | 0 | 0 | 0 | 1 (11) | 0 | 0 | 0 | 6 (17) | 0 | 7 (10) | 0 |
| TEAEs, n (%) . | Phase 1 part . | Phase 2 part (n = 35) . | All treated (n = 72) . | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Dose escalation . | Dose expansion 1.8 mg/m2 (n = 13) . | |||||||||||
| 1.2 mg/m2 (n = 3) . | 1.6 mg/m2 (n = 12) . | 1.8 mg/m2 (n = 9) . | ||||||||||
| Any grade . | Grade ≥3 . | Any grade . | Grade ≥3 . | Any grade . | Grade ≥3 . | Any grade . | Grade ≥3 . | Any grade . | Grade ≥3 . | Any grade . | Grade ≥3 . | |
| Thrombocytopenia* | 2 (67) | 1 (33) | 4 (33) | 3 (25) | 4 (44) | 4 (44) | 4 (31) | 4 (31) | 12 (34) | 12 (34) | 26 (36) | 24 (33) |
| Neutropenia†,‡ | 1 (33) | 1 (33) | 2 (17) | 2 (17) | 5 (56) | 5 (56) | 3 (23) | 3 (23) | 9 (26) | 7 (20) | 20 (28) | 18 (25) |
| AST increased | 0 | 0 | 3 (25) | 0 | 5 (56) | 0 | 3 (23) | 0 | 8 (23) | 2 (6) | 19 (26) | 2 (3) |
| Nausea | 0 | 0 | 2 (17) | 0 | 2 (22) | 0 | 3 (23) | 0 | 8 (23) | 0 | 15 (21) | 0 |
| Vomiting | 0 | 0 | 2 (17) | 0 | 2 (22) | 1 (11) | 2 (15) | 0 | 6 (17) | 0 | 12 (17) | 1 (1) |
| Fatigue | 0 | 0 | 5 (42) | 0 | 1 (11) | 0 | 1 (8) | 0 | 4 (11) | 0 | 11 (15) | 0 |
| Febrile neutropenia | 0 | 0 | 0 | 0 | 0 | 0 | 2 (15) | 2 (15) | 9 (26) | 7 (20) | 11 (15) | 9 (13) |
| AP increased | 0 | 0 | 0 | 0 | 4 (44) | 1 (11) | 1 (8) | 0 | 5 (14) | 0 | 10 (14) | 1 (1) |
| Anemia§ | 0 | 0 | 1 (8) | 1 (8) | 2 (22) | 1 (11) | 2 (15) | 2 (15) | 5 (14) | 4 (11) | 10 (14) | 8 (11) |
| GGT increased | 1 (33) | 0 | 0 | 0 | 5 (56) | 1 (11) | 0 | 0 | 3 (9) | 0 | 9 (13) | 1 (1) |
| ALT increased | 0 | 0 | 1 (8) | 1 (8) | 1 (11) | 1 (11) | 1 (8) | 0 | 5 (14) | 0 | 8 (11) | 2 (3) |
| Pyrexia | 0 | 0 | 0 | 0 | 1 (11) | 0 | 2 (15) | 0 | 5 (14) | 0 | 8 (11) | 0 |
| Hyperbilirubinemia | 0 | 0 | 0 | 0 | 1 (11) | 0 | 0 | 0 | 6 (17) | 0 | 7 (10) | 0 |
Includes entries under the preferred term “platelets decreased.”
Includes entries under the preferred term “neutrophil count decreased.”
One patient with grade 3 neutropenia had a prior event of treatment-related grade 4 neutropenia recorded after the data snapshot and was not included in this table.
Includes entries under the preferred term “hemoglobin count decreased.”