Table 3 Treatment-emergent adverse events occuring in 20% or more of participants.
Part A - Dose Escalation | Part B- Dose Expansion | RP2D (Parts A + B) | Total | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
DL1 (N = 7) | DL2 (N = 24) | DL3 (N = 11) | DL2 (N = 23) | DL2 (N = 47) | (N = 65) | |||||||
All grades | Gr 3-4 | All grades | Gr 3-4 | All grades | Gr 3-4 | All grades | Gr 3-4 | All grades | Gr 3-4 | All grades | Gr 3-4 | |
Any | 7 (100%) | 5 (71%) | 24 (100%) | 20 (83%) | 11 (100%) | 10 (91%) | 23 (100%) | 20 (87%) | 47 (100%) | 40 (85%) | 65 (100%) | 55 (85%) |
Any hematologic | 5 (71%) | 5 (71%) | 21 (88%) | 20 (83%) | 10 (91%) | 10 (91%) | 21 (91%) | 20 (87%) | 42 (89%) | 40 (85%) | 57 (88%) | 55 (85%) |
Neutropenia | 4 (57%) | 4 (57%) | 19 (79%) | 17 (71%) | 10 (91%) | 10 (91%) | 17 (74%) | 17 (74%) | 36 (77%) | 34 (72%) | 50 (77%) | 48 (74%) |
Thrombocytopenia | 2 (29%) | 2 (29%) | 10 (42%) | 7 (29%) | 7 (64%) | 6 (55%) | 13 (57%) | 10 (44%) | 23 (49%) | 17 (36%) | 32 (49%) | 25 (39%) |
Anemia | 2 (29%) | 2 (29%) | 10 (42%) | 8 (33%) | 6 (55%) | 5 (46%) | 12 (52%) | 9 (39%) | 22 (47%) | 17 (36%) | 30 (46%) | 25 (39%) |
Lymphopenia | 1 (14%) | 1 (14%) | 5 (21%) | 5 (21%) | 4 (36%) | 4 (36%) | 4 (17%) | 3 (13%) | 9 (19%) | 8 (17%) | 14 (22%) | 13 (20%) |
Infections | 0 (0%) | 0 (0%) | 8 (33%) | 2 (8%) | 4 (36%) | 0 (0%) | 9 (39%) | 1 (4%) | 17 (36%) | 3 (6%) | 21 (32%) | 3 (5%) |
Fatigue | 1 (14%) | 0 (0%) | 7 (29%) | 0 (0%) | 5 (46%) | 0 (0%) | 6 (26%) | 0 (0%) | 13 (28%) | 0 (0%) | 19 (29%) | 0 (0%) |
Diarrhea | 2 (29%) | 0 (0%) | 5 (21%) | 0 (0%) | 6 (55%) | 0 (0%) | 5 (22%) | 1 (4%) | 10 (21%) | 1 (2%) | 18 (28%) | 1 (2%) |
Nausea | 0 (0%) | 0 (0%) | 5 (21%) | 0 (0%) | 6 (55%) | 0 (0%) | 7 (30%) | 0 (0%) | 12 (26%) | 0 (0%) | 18 (28%) | 0 (0%) |
Constipation | 0 (0%) | 0 (0%) | 5 (21%) | 0 (0%) | 2 (18%) | 0 (0%) | 7 (30%) | 0 (0%) | 12 (26%) | 0 (0%) | 14 (22%) | 0 (0%) |
Headache | 1 (14%) | 0 (0%) | 6 (25%) | 0 (0%) | 3 (27%) | 0 (0%) | 6 (26%) | 0 (0%) | 12 (26%) | 0 (0%) | 16 (25%) | 0 (0%) |
Peripheral edema | 0 (0%) | 0 (0%) | 6 (25%) | 0 (0%) | 3 (27%) | 0 (0%) | 4 (17%) | 0 (0%) | 10 (21%) | 0 (0%) | 13 (20%) | 0 (0%) |
Hypocalcemia | 0 (0%) | 0 (0%) | 7 (29%) | 0 (0%) | 4 (36%) | 0 (0%) | 4 (17%) | 0 (0%) | 11 (23%) | 0 (0%) | 15 (23%) | 0 (0%) |
Hypokalemia | 1 (14%) | 0 (0%) | 3 (13%) | 0 (0%) | 4 (36%) | 0 (0%) | 6 (26%) | 0 (0%) | 9 (19%) | 0 (0%) | 14 (22%) | 0 (0%) |
Hyponatremia | 1 (14%) | 0 (0%) | 5 (21%) | 0 (0%) | 5 (46%) | 0 (0%) | 3 (13%) | 0 (0%) | 8 (17%) | 0 (0%) | 14 (22%) | 0 (0%) |
Alanine aminotransferase increase | 0 (0%) | 0 (0%) | 4 (17%) | 1 (4%) | 4 (36%) | 2 (18%) | 5 (22%) | 2 (9%) | 9 (19%) | 3 (6%) | 13 (20%) | 5 (8%) |
Aspartate aminotransferase increase | 1 (14%) | 0 (0%) | 4 (17%) | 1 (4%) | 4 (36%) | 2 (18%) | 4 (17%) | 2 (9%) | 8 (17%) | 3 (6%) | 13 (20%) | 5 (8%) |
