Table 2 Summary of safety profiles.

From: GX-I7, a long-acting IL-7, safely and effectively increased peripheral CD8+/CD4+ T cells and TILs in patients with locally advanced or metastatic solid tumours

Group

GX-I760 µg/kg (n = 3)

GX-I7120 µg/kg (n = 3)

GX-I7240 µg/kg (n = 3)

GX-I7 480 µg/kg (n = 3)

GX-I7 720 µg/kg (n = 6)

GX-I7 960 µg/kg (n = 3)

GX-I7 1200 µg/kg (n = 12)

GX-I7 1700 µg/kg (n = 2)

Total (n = 35)

Subjects with Treatment-Emergent Adverse Events, n (%) [Events]

 

3 (100.0) [14]

3 (100.0) [30]

3 (100.0) [15]

3 (100.0) [21]

6 (100.0) [35]

3 (100.0) [6]

12 (100.0) [88]

2 (100.0) [16]

35 (100.0) [225]

Subject with Adverse Drug Reactions, n (%) [Events]

 

3 (100.0) [6]

2 (66.7) [9]

3 (100) [6]

2 (66.7) [8]

4 (66.7) [18]

2 (66.7) [4]

10 (83.3) [49]

2 (100.0) [16]

28 (80.0) [116]

General disorders and administration site conditions

 Injection site reaction

3 (100.0) [6]

2 (66.7) [5]

3 (100.0) [3]

2 (66.7) [6]

3 (50.0) [9]

1 (33.3) [3]

9 (75.0) [24]

2 (100.0) [5]

25 (71.4) [61]

  Grade 1

2(66.7)

 

1(33.3)

1(33.3)

1(16.7)

 

4(33.3)

1(50.0)

 

  Grade 2

1(33.3)

2(66.7)

2(66.7)

1(33.3)

2(33.3)

1(33.3)

5(41.7)

1(50.0)

 

 Pyrexia

0

1 (33.3) [1]

1 (33.3) [1]

1 (33.3) [2]

1 (16.7) [2]

1 (33.3) [1]

5 (41.7) [11]

2 (100.0) [3]

12 (34.3) [21]

  Grade 1

 

1(33.3)

1(33.3)

1(33.3)

 

1(33.3)

5(41.7)

1(50.0)

 

  Grade 2

       

1(50.0)

 

 Fatigue

0

0

0

0

1 (16.7) [1]

0

3 (25.0) [3]

0

4 (11.4) [4]

  Grade 1

      

1(8.3)

  

  Grade 2

      

1(8.3)

  

  Grade 3

    

1(16.7)

 

1(8.3)

  

Skin and subcutaneous tissue disorders

 Rash

0

0

0

0

3 (50.0) [4]

0

2 (16.7) [2]

2 (100.0) [2]

7 (20.0) [8]

  Grade 1

      

1(8.3)

1(50.0)

 

  Grade 2

    

3(50.0)

 

1(8.3)

1(50.0)

 

 Rash popular

0

1 (33.3) [1]

0

0

0

0

0

0

1 (2.9) [1]

  Grade 1

 

1(33.3)

       

Immune system disorders

 Anaphylactic reaction

0

0

0

0

0

0

0

1 (50.0) [1]

1 (2.9) [1]

  Grade 3

       

1(50.0)

 

 Hypersensitivity

0

0

0

0

0

0

0

1 (50.0) [1]

1 (2.9) [1]

  Grade 3

       

1(50.0)

 

Gastrointestinal disorders

 Nausea

0

0

0

0

0

0

1 (8.3) [1]

0

1 (2.9) [1]

  Grade 2

      

1(8.3)

  

Investigations

 Platelet count decreased

0

0

0

0

0

0

0

1 (50.0) [1]

1 (2.9) [1]

  Grade 2

       

1(50.0)

 
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