Table1: Profiles of patients in the full analysis set for safety assessment (N=20) 



Clinical variables

 

0.3 mg (n=7)

1.0 mg (n=7)

3.0 mg (n=6)

Total (n=20)

Gender

Men: Women

2:5

5:2

3:3

10:10

Age

Median (min-max)

69.5 (53-78)

63.0 (59-84)

64.4 (41-66)

65.1(41-84)

Type of cancer

Pancreatic cancer

5

2

5

12

 

Colon cancer

2

3

1

6

 

Gastric cancer

0

1

0

1

 

Bile duct cancer

0

1

0

1

Metastasis

(positive: negative)

7:0

5:2

5:1

17:3

Prior surgery

(positive: negative)

4:3

5:2

3:3

12:8

Prior radiation therapy

(positive: negative)

2:5

2:5

3:3

7:13

Prior chemotherapy

(positive: negative)

6:1

6:1

6:0

18:2

ECOG PS

(0:1)

1:6

1:6

2:4

4:16

Treatment-related AEs

 

 

Fever

Grade 1

1

 

 

1

Injection site extravasation

Grade 2

 

 

1

1

Injection site reaction

Grade 1

1

 

1

2

Skin induration

Grade 1

1

1

 

2