Table 2 Summary of treatment related adverse events that occurred in ≥10% of the patients

From: First-in-human study of DP303c, a HER2-targeted antibody-drug conjugate in patients with HER2 positive solid tumors

AEs, n(%)

<3.0 mg/kg n = 10

≥3.0 mg/kg n = 84

Total n = 94

 

Any grade

Grade ≥ 3

Any grade

Grade ≥ 3

Any grade

Grade ≥ 3

Overall

10 (100)

1 (10.0)

84 (100)

33 (39.3)

94 (100)

34 (36.2)

Corneal disease

5 (50.0)

0

77 (91.7)

2 (2.4)

82 (87.2)

2 (2.1)

Blurred vision

5 (50.0)

0

53 (63.1)

15 (17.9)

58 (61.7)

15 (16.0)

Dry eye

6 (60.0)

0

48 (57.1)

6 (7.1)

54 (57.4)

6 (6.4)

Peripheral neuropathy

4 (40.0)

1 (10.0)

40 (47.6)

4 (4.8)

44 (46.8)

5 (5.3)

Hypertriglyceridemia

3 (30.0)

0

39 (46.4)

1 (1.2)

42 (44.7)

1 (1.1)

Alopecia

2 (20.0)

0

32 (38.1)

0

34 (36.2)

0

Increased AST

0

0

30 (35.7)

1 (1.2)

30 (31.9)

1 (1.1)

Increased ALT

1 (10.0)

0

27 (32.1)

2 (2.4)

28 (29.8)

2 (2.1)

Hypercholesterolemia

1 (10.0)

0

25 (29.8)

0

26 (27.7)

0

Anemia

2 (20.0)

0

23 (27.4)

0

25 (26.6)

0

Proteinuria

1 (10.0)

0

24 (28.6)

0

25 (26.6)

0

Hyponatremia

1 (10.0)

0

23 (27.4)

0

24 (25.5)

0

Hyperglycemia

1 (10.0)

0

22 (26.2)

0

23 (24.5)

0

Fatigue

3 (30.0)

0

15 (17.9)

0

18 (19.1)

0

Eye pain

0

0

18 (21.4)

1 (1.2)

18 (19.1)

1 (1.1)

Increased lacrimation

0

0

17 (20.2)

0

17 (18.1)

0

Photophobia

0

0

17 (20.2)

0

17 (18.1)

0

Myalgia

0

0

16 (19.0)

1 (1.2)

16 (17.0)

1 (1.1)

Decreased appetite

2 (20.0)

0

13 (15.5)

0

15 (16.0)

0

Hypercalcemia

0

0

14 (16.7)

0

14 (14.9)

0

Eye discharge

2 (20.0)

0

12 (14.3)

0

14 (14.9)

0

Increased CPK

2 (20.0)

0

12 (14.3)

0

14 (14.9)

0

Neutropenia

0

0

14 (16.7)

2 (2.4)

14 (14.9)

2 (2.1)

Leucopenia

1 (10.0)

0

12 (14.3)

0

13 (13.8)

0

Foreign body sensation in eyes

0

0

13 (15.5)

0

13 (13.8)

0

Increased blood bilirubin

1 (10.0)

0

12 (14.3)

1 (1.2)

13 (13.8)

1 (1.1)

Hyperuricemia

1 (10.0)

0

11 (13.1)

0

12 (12.8)

0

Pruritus

1 (10.0)

0

11 (13.1)

0

12 (12.8)

0

Weight loss

0

0

12 (14.3)

0

12 (12.8)

0

Hypoalbuminemia

1 (10.0)

0

10 (11.9)

0

11 (11.7)

0

  1. Data were expressed as n (%). Treatment-related adverse events are summarized by System Organ Class and Preferred Term according to MedDRA v25.1 for events occurring in >10% of patients in the safety analysis set.
  2. AE adverse event, ALT alanine aminotransferase, AST aspartate aminotransferase, CPK creatine phosphokinase.
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