Treatment-emergent AEs recorded in the phase 1 population and in patients treated at the RP2D
| AE . | Phase 1 population (n = 26), n (%) . | Patients treated at the RP2D* (n = 8), n (%) . | ||
|---|---|---|---|---|
| Grades 1-2 . | Grades 3-4 . | Grades 1-2 . | Grades 3-4 . | |
| Alkaline phosphatase elevation | 9 (35) | 1 (4) | 2 (25) | 0 |
| Anemia | 12 (46) | 5 (19) | 5 (62) | 1 (12) |
| Anorexia | — | — | 2 (25) | 0 |
| AST elevation | — | — | 2 (25) | 0 |
| Constipation | — | — | 3 (37) | 0 |
| Cough | 3 (12) | — | 4 (50) | 0 |
| Creatinine elevation | 8 (31) | — | 3 (37) | 0 |
| Diarrhea | 7 (27) | — | 2 (25) | 1 (12) |
| Fatigue | 10 (38) | 1 (4) | 3 (37) | 0 |
| Febrile neutropenia | — | 2 (8) | — | 1 (12) |
| Fever | 3 (12) | — | 3 (37) | 1 (12) |
| General disorders and administration site conditions | 4 (15) | — | 2 (25) | 0 |
| Hiccups | — | — | 2 (25) | 0 |
| Hyperbilirubinemia | — | — | — | 1 (12) |
| Hypercalcemia | 3 (12) | — | — | — |
| Hyperchloremia | — | — | 2 (25) | 0 |
| Hyperglycemia | 21 (81) | 1 (4) | 7 (87) | 1 (12) |
| Hypermagnesemia | 1 (4) | 1 (4) | — | — |
| Hypoalbuminemia | 13 (50) | — | 4 (50) | 0 |
| Hypocalcemia | 5 (19) | — | — | — |
| Hypochloremia | 5 (19) | — | 3 (37) | 0 |
| Hypogammaglobulinemia | 8 (31) | — | — | — |
| Hypoglycemia | 3 (12) | — | — | — |
| Hypokalemia | 4 (15) | 1 (4) | 2 (25) | — |
| Hyponatremia | 12 (46) | 2 (8) | 2 (25) | 0 |
| Hypophosphatemia | — | — | 2 (25) | 0 |
| Hypoproteinemia | 17 (65) | — | 5 (62) | 0 |
| Hypotension | — | 3 (12) | — | — |
| Insomnia | — | — | 2 (25) | 0 |
| Lung infection | — | — | — | 2 (25) |
| Lymphocyte count decrease | 10 (38) | 11 (42) | 3 (37) | 2 (25) |
| Mucositis oral | 4 (15) | — | 2 (25) | 0 |
| Nausea | 14 (54) | 1 (4) | 4 (50) | 0 |
| Neutrophil count decrease | 6 (23) | 11 (42) | 1 (12) | 3 (37) |
| Pain | 3 (12) | — | — | — |
| Platelet count decrease | 14 (54) | 7 (27) | 2 (25) | 5 (62) |
| Pleural effusion | — | 1 (4) | — | — |
| Urinary tract infection | — | 1 (4) | — | — |
| Vomiting | 12 (46) | — | 3 (37) | 0 |
| White blood cell count decrease | 13 (50) | 6 (23) | 4 (50) | 2 (25) |
| AE . | Phase 1 population (n = 26), n (%) . | Patients treated at the RP2D* (n = 8), n (%) . | ||
|---|---|---|---|---|
| Grades 1-2 . | Grades 3-4 . | Grades 1-2 . | Grades 3-4 . | |
| Alkaline phosphatase elevation | 9 (35) | 1 (4) | 2 (25) | 0 |
| Anemia | 12 (46) | 5 (19) | 5 (62) | 1 (12) |
| Anorexia | — | — | 2 (25) | 0 |
| AST elevation | — | — | 2 (25) | 0 |
| Constipation | — | — | 3 (37) | 0 |
| Cough | 3 (12) | — | 4 (50) | 0 |
| Creatinine elevation | 8 (31) | — | 3 (37) | 0 |
| Diarrhea | 7 (27) | — | 2 (25) | 1 (12) |
| Fatigue | 10 (38) | 1 (4) | 3 (37) | 0 |
| Febrile neutropenia | — | 2 (8) | — | 1 (12) |
| Fever | 3 (12) | — | 3 (37) | 1 (12) |
| General disorders and administration site conditions | 4 (15) | — | 2 (25) | 0 |
| Hiccups | — | — | 2 (25) | 0 |
| Hyperbilirubinemia | — | — | — | 1 (12) |
| Hypercalcemia | 3 (12) | — | — | — |
| Hyperchloremia | — | — | 2 (25) | 0 |
| Hyperglycemia | 21 (81) | 1 (4) | 7 (87) | 1 (12) |
| Hypermagnesemia | 1 (4) | 1 (4) | — | — |
| Hypoalbuminemia | 13 (50) | — | 4 (50) | 0 |
| Hypocalcemia | 5 (19) | — | — | — |
| Hypochloremia | 5 (19) | — | 3 (37) | 0 |
| Hypogammaglobulinemia | 8 (31) | — | — | — |
| Hypoglycemia | 3 (12) | — | — | — |
| Hypokalemia | 4 (15) | 1 (4) | 2 (25) | — |
| Hyponatremia | 12 (46) | 2 (8) | 2 (25) | 0 |
| Hypophosphatemia | — | — | 2 (25) | 0 |
| Hypoproteinemia | 17 (65) | — | 5 (62) | 0 |
| Hypotension | — | 3 (12) | — | — |
| Insomnia | — | — | 2 (25) | 0 |
| Lung infection | — | — | — | 2 (25) |
| Lymphocyte count decrease | 10 (38) | 11 (42) | 3 (37) | 2 (25) |
| Mucositis oral | 4 (15) | — | 2 (25) | 0 |
| Nausea | 14 (54) | 1 (4) | 4 (50) | 0 |
| Neutrophil count decrease | 6 (23) | 11 (42) | 1 (12) | 3 (37) |
| Pain | 3 (12) | — | — | — |
| Platelet count decrease | 14 (54) | 7 (27) | 2 (25) | 5 (62) |
| Pleural effusion | — | 1 (4) | — | — |
| Urinary tract infection | — | 1 (4) | — | — |
| Vomiting | 12 (46) | — | 3 (37) | 0 |
| White blood cell count decrease | 13 (50) | 6 (23) | 4 (50) | 2 (25) |
For the phase 1 population, grade 1 and 2 AEs occurring in more than 10 of patients are reported, regardless of attribution to study drugs. For patients treated at the RP2D, grade 1 and 2 AEs occurring in at least 2 patients are reported, regardless of attribution to study drugs.
This group includes 3 patients enrolled in the phase 1 trial and the 5 patients treated in the exploratory cohort.