Table 2 Most common TRAEs (any and grade ≥3) that occurred in 10% or more patients.
From: Phase I study of A166, an antibody‒drug conjugate in advanced HER2-expressing solid tumours
TRAEs No. of patients (%) | ≤2.4 mg/kg (N = 13) | 3.6 mg/kg (N = 3) | 4.8 mg/kg (N = 27) | 6.0 mg/kg (N = 38) | Total (N = 81) | |||||
|---|---|---|---|---|---|---|---|---|---|---|
Total | Grade ≥ 3 | Total | Grade ≥ 3 | Total | Grade ≥ 3 | Total | Grade ≥ 3 | Total | Grade ≥ 3 | |
Overall | 12 (92.3) | 3 (23.1) | 3 (100) | 2 (66.7) | 27 (100) | 14 (51.9) | 38 (100) | 21 (55.3) | 80 (98.8) | 40 (49.4) |
Corneal epitheliopathy | 1 (7.7) | 0 | 3 (100) | 1 (33.3) | 27 (100) | 11 (40.7) | 37 (97.4) | 13 (34.2) | 68 (84.0) | 25 (30.9) |
Blurred vision | 0 | 0 | 1 (33.3) | 0 | 23 (85.2) | 7 (25.9) | 36 (94.7) | 8 (21.1) | 60 (74.1) | 15 (18.5) |
Peripheral sensory neuropathy | 1 (7.7) | 0 | 0 | 0 | 17 (63.0) | 1 (3.7) | 25 (65.8) | 4 (10.5) | 43 (53.1) | 5 (6.2) |
Dry eyes | 0 | 0 | 3 (100) | 0 | 9 (33.3) | 3 (11.1) | 14 (36.8) | 3 (7.9) | 26 (32.1) | 6 (7.4) |
Muscular weakness | 0 | 0 | 0 | 0 | 13 (48.1) | 1 (3.7) | 10 (26.3) | 1 (2.6) | 23 (28.4) | 2 (2.5) |
Anaemia | 3 (23.1) | 1 (7.7) | 1 (33.3) | 0 | 4 (14.8) | 0 | 11 (28.9) | 1 (2.6) | 19 (23.5) | 2 (2.5) |
Increased CPK | 0 | 0 | 1 (33.3) | 0 | 8 (29.6) | 0 | 9 (23.7) | 0 | 18 (22.2) | 0 |
Alopecia | 0 | 0 | 0 | 0 | 3 (11.1) | 0 | 15 (39.5) | 0 | 18 (22.2) | 0 |
Increased ALT | 3 (23.1) | 0 | 1 (33.3) | 0 | 5 (18.5) | 0 | 6 (15.8) | 0 | 15 (18.5) | 0 |
Increased AST | 3 (23.1) | 0 | 0 | 0 | 6 (22.2) | 0 | 6 (15.8) | 0 | 15 (18.5) | 0 |
Increased myoglobin blood | 0 | 0 | 0 | 0 | 6 (22.2) | 0 | 8 (21.1) | 0 | 14 (17.3) | 0 |
Hyponatremia | 3 (23.1) | 1 (7.7) | 1 (33.3) | 0 | 4 (14.8) | 0 | 5 (13.2) | 1 (2.6) | 13 (16.0) | 2 (2.5) |
Hypomagnesemia | 0 | 0 | 0 | 0 | 8 (29.6) | 0 | 5 (13.2) | 0 | 13 (16.0) | 0 |
Proteinuria | 4 (30.8) | 0 | 0 | 0 | 3 (11.1) | 0 | 4 (10.5) | 0 | 11 (13.6) | 0 |
Blood urine present | 0 | 0 | 0 | 0 | 5 (18.5) | 0 | 4 (10.5) | 0 | 9 (11.1) | 0 |
Leucopenia | 2 (15.4) | 0 | 0 | 0 | 0 | 0 | 7 (18.4) | 1 (2.6) | 9 (11.1) | 1 (1.2) |
Increased blood bilirubin | 2 (15.4) | 0 | 0 | 0 | 3 (11.1) | 0 | 4 (10.5) | 0 | 9 (11.1) | 0 |
