Table 2 Summary of treatment-related adverse events
From: First-in-human phase Ia study of the PI3Kα inhibitor CYH33 in patients with solid tumors
n (%) | DL1–4 CYH33, 1–20 mg QD n = 10 | DL5 CYH33, 30 mg QD n = 12 | DL6 CYH33, 40 mg QD n = 24 | All patients CYH33, 1–60 mg QD n = 51 |
|---|---|---|---|---|
TRAEs leading to dose interruption | 2 (20.0) | 10 (83.3) | 19 (79.2) | 36 (70.6) |
TRAEs leading to dose reduction | 1 (10.0) | 0 | 5 (20.8) | 6 (11.8) |
TRAEs leading to dose discontinuation | 0 | 1 (8.3) | 2 (8.3) | 4 (7.8) |
TRAEs leading to death | 0 | 0 | 0 | 0 |
Treatment-related serious adverse events | 0 | 1 (8.3) | 4 (16.7) | 6 (11.8) |
TRAEs occurring in ≥ 10% of patients | 7 (70.0) | 12 (100) | 23 (95.8) | 47 (92.2) |
Hyperglycemia | 7 (70.0) | 11 (91.7) | 23 (95.8) | 46 (90.2) |
Decreased appetite | 3 (30.0) | 4 (33.3) | 12 (50.0) | 21 (41.2) |
Nausea | 3 (30.0) | 6 (50.0) | 9 (37.5) | 19 (37.3) |
Weight loss | 1 (10.0) | 4 (33.3) | 9 (37.5) | 16 (31.4) |
Diarrhea | 3 (30.0) | 2 (16.7) | 7 (29.2) | 15 (29.4) |
Peripheral edema | 1 (10.0) | 4 (33.3) | 8 (33.3) | 13 (25.5) |
Vomiting | 3 (30.0) | 3 (25.0) | 6 (25.0) | 13 (25.5) |
Rash | 1 (10.0) | 2 (16.7) | 6 (25.0) | 9 (17.6) |
Fatigue | 1 (10.0) | 2 (16.7) | 6 (25.0) | 9 (17.6) |
Facial edema | 0 | 4 (33.3) | 4 (16.7) | 8 (15.7) |
Mouth ulceration | 1 (10.0) | 0/0 | 5 (20.8) | 6 (11.8) |
Hyponatremia | 0 | 4 (33.3) | 2 (8.3) | 6 (11.8) |
Grade ≥ 3 TRAEs in all patients | 2 (20.0) | 7 (58.3) | 19 (79.2) | 33 (64.7) |
Hyperglycemia | 2 (20.0) | 7 (58.3) | 17 (70.8) | 30 (58.8) |
Peripheral edema | 0 | 0 | 4 (16.7) | 4 (7.8) |
Diarrhea | 0 | 0 | 1 (4.2) | 2 (3.9) |
Decreased appetite | 0 | 0 | 1 (4.2) | 1 (2.0) |
Mouth ulceration | 0 | 0 | 1 (4.2) | 1 (2.0) |
Face oedema | 0 | 0 | 1 (4.2) | 1 (2.0) |
Fatigue | 0 | 0 | 1 (4.2) | 1 (2.0) |
Generalized oedema | 0 | 1 (8.3) | 0 | 1 (2.0) |
Rash | 0 | 0 | 1 (4.2) | 1 (2.0) |
Dizziness | 0 | 0 | 1 (4.2) | 1 (2.0) |
White blood cell count decreased | 0 | 0 | 1 (4.2) | 1 (2.0) |
Diabetic ketosis | 0 | 1 (8.3) | 0 | 1 (2.0) |
Nausea | 0 | 0 | 0 | 1 (2.0) |
Blood glucose increased | 0 | 0 | 0 | 1 (2.0) |
Electrocardiogram QT prolonged | 1 (10.0) | 0 | 0 | 1 (2.0) |
