Cumulative Proportion of Patients with Antibodies to PIXY321, IL-3, or GM-CSF
Study Portion . | Dose Level . | Initial n . | PIXY321 . | IL-3 . | GM-CSF . | |||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
ELISA . | Neutralizing . | ELISA . | Neutralizing . | ELISA . | Neutralizing . | |||||||||
Cycle 1 . | Cycle 2 . | Cycle 1 . | Cycle 2 . | Cycle 1 . | Cycle 2 . | Cycle 1 . | Cycle 2 . | Cycle 1 . | Cycle 2 . | Cycle 1 . | Cycle 2 . | |||
Part A | 135 | 5 | 3/5 | 2/5 | 3/5 | 0/5 | 1/5 | 0/5 | ||||||
250 | 6 | 1/6 | 0/6 | 1/6 | 0/6 | 0/6 | 0/6 | |||||||
500 | 4 | 3/4 | 2/4 | 3/4 | 0/4 | 0/4 | 0/4 | |||||||
750 | 5 | 2/5 | 2/5 | 4/5 | 0/5 | 1/5 | 0/5 | |||||||
1,000 | 4 | 1/4 | 0/4 | 2/4 | 0/4 | 0/4 | 0/4 | |||||||
Total | 24 | 10/24 | 6/24 | 13/24 | 0/24 | 2/24 | 0/24 | |||||||
Part A | (42%) | (25%) | (54%) | (0%) | (8%) | (0%) | ||||||||
Part B | 750 | 6 | 4/6 | 4/5 | 2/6 | 4/5 | 3/6 | 3/5 | 1/6 | 1/3 | 2/6 | 2/5 | 1/6 | 1/4 |
1,000 | 4 | 4/4 | 4/4 | 2/4 | 3/3 | 4/4 | 4/4 | 0/4 | 0/2 | 2/4 | 2/4 | 2/4 | 1/3 | |
1,250 | 5 | 5/5 | 5/5 | 4/5 | 5/5 | 5/5 | 5/5 | 1/5 | 1/2 | 4/5 | 5/5 | 2/5 | 3/4 | |
Total | 15 | 13/15 | 13/14 | 8/15 | 12/13 | 12/15 | 12/14 | 2/15 | 2/7 | 8/15 | 9/14 | 4/15 | 5/11 | |
Part B | (87%) | (93%) | (53%) | (92%) | (80%) | (86%) | (13%) | (29%) | (53%) | (64%) | (27%) | (45%) |
Study Portion . | Dose Level . | Initial n . | PIXY321 . | IL-3 . | GM-CSF . | |||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
ELISA . | Neutralizing . | ELISA . | Neutralizing . | ELISA . | Neutralizing . | |||||||||
Cycle 1 . | Cycle 2 . | Cycle 1 . | Cycle 2 . | Cycle 1 . | Cycle 2 . | Cycle 1 . | Cycle 2 . | Cycle 1 . | Cycle 2 . | Cycle 1 . | Cycle 2 . | |||
Part A | 135 | 5 | 3/5 | 2/5 | 3/5 | 0/5 | 1/5 | 0/5 | ||||||
250 | 6 | 1/6 | 0/6 | 1/6 | 0/6 | 0/6 | 0/6 | |||||||
500 | 4 | 3/4 | 2/4 | 3/4 | 0/4 | 0/4 | 0/4 | |||||||
750 | 5 | 2/5 | 2/5 | 4/5 | 0/5 | 1/5 | 0/5 | |||||||
1,000 | 4 | 1/4 | 0/4 | 2/4 | 0/4 | 0/4 | 0/4 | |||||||
Total | 24 | 10/24 | 6/24 | 13/24 | 0/24 | 2/24 | 0/24 | |||||||
Part A | (42%) | (25%) | (54%) | (0%) | (8%) | (0%) | ||||||||
Part B | 750 | 6 | 4/6 | 4/5 | 2/6 | 4/5 | 3/6 | 3/5 | 1/6 | 1/3 | 2/6 | 2/5 | 1/6 | 1/4 |
1,000 | 4 | 4/4 | 4/4 | 2/4 | 3/3 | 4/4 | 4/4 | 0/4 | 0/2 | 2/4 | 2/4 | 2/4 | 1/3 | |
1,250 | 5 | 5/5 | 5/5 | 4/5 | 5/5 | 5/5 | 5/5 | 1/5 | 1/2 | 4/5 | 5/5 | 2/5 | 3/4 | |
Total | 15 | 13/15 | 13/14 | 8/15 | 12/13 | 12/15 | 12/14 | 2/15 | 2/7 | 8/15 | 9/14 | 4/15 | 5/11 | |
Part B | (87%) | (93%) | (53%) | (92%) | (80%) | (86%) | (13%) | (29%) | (53%) | (64%) | (27%) | (45%) |