Table 3 Any grade treatment-related adverse events (TRAEs) occurring in ā‰„5% of patients and all grade ā‰„3 TRAEs in the phase Ib and phase II studies

From: Efficacy and safety of KN026, a bispecific anti-HER2 antibody, in combination with KN046, an anti-CTLA4/PD-L1 antibody, in patients with advanced HER2-positive nonbreast cancer: a combined analysis of a phase Ib and a phase II study

Ā 

Phase 1b

Phase 2

Total

Ā 

Nā€‰=ā€‰47 (%)

Nā€‰=ā€‰66 (%)

Nā€‰=ā€‰113 (%)

Gradeā€‰ā‰„ā€‰3

All grades

Gradeā€‰ā‰„ā€‰3

All grades

Gradeā€‰ā‰„ā€‰3

All grades

All

10 (21.3)

44 (93.6)

25 (37.9)

54 (97.0)

35 (31.0)

108 (95.6)

Infusion reactions

1 (2.1)

17 (36.2)

1 (1.5)

27 (40.9)

2 (1.8)

44 (38.9)

Anemia

2 (4.3)

22 (46.8)

4 (6.1)

20 (30.3)

6 (5.3)

42 (37.2)

Elevated AST

0

15 (31.9)

4 (6.1)

20 (30.3)

4 (3.5)

35 (31.0)

Diarrhea

0

13 (27.7)

2 (3.0)

21 (31.8)

2 (1.8)

34 (30.1)

Elevated ALT

1 (2.1)

12 (25.5)

2 (3.0)

20 (30.3)

3 (2.7)

32 (28.3)

Leukemia

0

9 (19.1)

0

19 (28.8)

0

28 (24.8)

Rash

0

11 (23.4)

1 (1.5)

16 (24.2)

1 (0.9)

27 (23.9)

Elevated TBIL

0

9 (19.1)

0

11 (16.7)

0

20 (17.7)

Neutropenia

1 (2.1)

7 (14.9)

0

13 (19.7)

1 (0.9)

20 (17.7)

Hypothyroidism

0

6

0

11 (16.7)

0

17 (15.0)

Elevated DBIL

0

1 (2.1)

2 (3.0)

15 (18.2)

2 (1.8)

16 (14.2)

Weight loss

0

2

1 (1.5)

12 (18.2)

1 (0.9)

14 (12.4)

Thrombocytopenia

1 (2.1)

8 (17.0)

1 (1.5)

5 (7.6)

2 (1.8)

13 (11.5)

Fever

0

3 (6.4)

1 (1.5)

8 (12.1)

1 (0.9)

11 (9.7)

Fatigue

0

1 (2.1)

1 (1.5)

9 (13.6)

1 (0.9)

10 (8.8)

Hyponatremia

0

3 (6.4)

1 (1.5)

6 (9.1)

1 (0.9)

9 (8.0)

Vomiting

0

2 (4.3)

1 (1.5)

7 (10.6)

1 (0.9)

9 (8.0)

Anorexia

0

0

0

9 (13.6)

0

9 (8.0)

Hypokalemia

0

3 (6.4)

1 (1.5)

5 (7.6)

1 (0.9)

8 (7.1)

Hyperthyroidism

0

3 (6.4)

0

5 (7.6)

0

8 (7.1)

Elevated creatine

0

2 (4.3)

0

6 (9.1)

0

8 (7.1)

Elevated GGT

1 (2.1)

2 (4.3)

0

5 (7.6)

1 (0.9)

7 (6.2)

Proteinuria

0

5 (10.6)

0

2 (3.0)

0

7 (6.2)

Pruritus

1

1 (2.1)

1 (1.5)

6 (9.1)

2 (1.8)

7 (6.2)

Elevated TSH

0

3 (6.4)

0

3 (4.5)

0

6 (5.3)

Elevated cTnI

0

2 (4.3)

1 (1.5)

3 (4.5)

1 (0.9)

5 (4.4)

Interstitial lung disease

0

3 (6.4)

1 (1.5)

2 (3.0)

1 (0.9)

5 (4.4)

Hypopituitarism

0

0

2 (3.0)

2 (3.0)

2 (1.8)

2 (1.8)

Abdominal pain

0

1 (2.1)

1 (1.5)

1 (1.5)

1 (0.9)

2 (1.8)

Abnormal liver function

1 (2.1)

2 (4.3)

0

0

1 (0.9)

2 (1.8)

Decreased RBC

0

1 (2.1)

1 (1.5)

1 (1.5)

1 (0.9)

2 (1.8)

Hyperglycemia

0

1 (2.1)

1 (1.5)

1 (1.5)

1 (0.9)

2 (1.8)

Macula

0

0

1 (1.5)

1 (1.5)

1 (0.9)

1 (0.9)

Pulmonary hypertension

1 (2.1)

1 (2.1)

0

0

1 (0.9)

1 (0.9)

Acute kidney injury

0

0

1 (1.5)

1 (1.5)

1 (0.9)

1 (0.9)

Immune-related enteritis

0

0

1 (1.5)

1 (1.5)

1 (0.9)

1 (0.9)

Immune-related gastritis

0

0

1 (1.5)

1 (1.5)

1 (0.9)

1 (0.9)

Encephalitis

1 (2.1)

1 (2.1)

0

0

1 (0.9)

1 (0.9)

Urinary tract infection

0

0

1 (1.5)

1 (1.5)

1 (0.9)

1 (0.9)

Hydronephrosis

0

0

1 (1.5)

1 (1.5)

1 (0.9)

1 (0.9)

Ureteral stricture

0

0

1 (1.5)

1 (1.5)

1 (0.9)

1 (0.9)

Immune-related hepatitis

0

0

1 (1.5)

1 (1.5)

1 (0.9)

1 (0.9)

Immune-related endocrine abnormalities

1 (2.1)

1 (2.1)

0

0

1 (0.9)

1 (0.9)

Hypoadrenalism

0

0

1 (1.5)

1 (1.5)

1 (0.9)

1 (0.9)

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