Table 3:
Patient ID+ | LMB-100 Dose (mcg/kg) | Cycle 1 | Cycle 2 | Cycle 3 | Cycle 4 | |||||
---|---|---|---|---|---|---|---|---|---|---|
| ||||||||||
ADAa | Cmaxb (ng/ml) | ADAa | Cmaxb (ng/ml) | ADAa | Cmaxb (ng/ml) | ADAa | Cmaxb (ng/ml) | |||
| ||||||||||
Multicenter Phase I | 1 | 45 | 0.436 | 620 | 2.996 | 2.1 | - | - | - | - |
2 | 65 | 0.025 | 1150 | 0.727 | 711 | - | - | - | - | |
3 | 100 | 0.848 | 495 | 3.094 | 2.1 | - | - | - | - | |
4 | 100 | 0.02 | 1790 | 0.024 | 1610 | 2.431 | 267 | 3.331 | - | |
5 | 100 | 0.025 | 1650 | 0.052 | 1360 | 2.418 | 2.1 | 3.44 | - | |
6 | 170 | 0.037 | 3040 | 0.02 | 1940 | - | - | - | - | |
7 | 170 | 0.028 | 3430 | 3.308 | 527 | - | - | - | - | |
8 | 170 | 0.024 | 1930 | 0.227 | 1550 | - | - | - | - | |
9 | 170 | 0.024 | 2760 | 0.105 | 3950 | 0.292 | 3490 | 1.604 | 2.1 | |
12 | 250 | 0.387 | 2960 | 3.286 | - | - | - | - | - | |
13 | 250 | 0.02 | 5480 | 0.049 | 4770 | - | - | - | - | |
14 | 250 | 0.019 | 4340 | - | - | - | - | - | - | |
15 | 250 | 0.454 | 3730 | 3.232 | 2.1 | - | - | - | - | |
NCI Phase I | 16 | 170 | 0.007 | 1991 | 1.846 | 1091 | 2.67 | 2.1 | 2.663 | 2.1 |
17 | 170 | 0.057 | 2286 | 2.466 | 297 | 2.69 | 70 | 2.681 | 2.1 | |
18 | 170 | 0.392 | 2760 | 2.721 | 4.4 | 2.619 | 2.1 | 2.661 | 2.1 | |
19 | 140 | 0.05 | 1054 | 0.164 | 681 | 2.758 | 2.1 | 2.744 | 2.1 | |
20 | 140 | 0.446 | 1124 | x | 2.1 | - | - | - | - | |
21 | 140 | 0.027 | 3118 | 2.31 | 2450 | 3.389 | 2.1 | 3.277 | 2.1 | |
22 | 140 | 0.007 | 2584 | 2.394 | 1099 | 3.432 | 2.1 | 3.433 | 2.1 | |
23 | 140 | 0.012 | 1721 | 3.236 | 2.1 | 3.562 | 2.1 | 3.743 | 2.1 | |
24 | 140 | 0.174 | 1526 | 3.598 | 27.8 | 3.623 | 20 | 3.639 | 2.1 | |
25 | 140 | 1.476 | 2689 | 2.863 | 5.1 | 2.967 | - | 2.979 | - |
Two patients who received only a single dose of LMB-100 at 200 mcg/kg are not included
Anti-LMB-100 antibodies (ADA) were measured prior to infusion
LMB-100 blood levels
ADA assay not performed
Patients did not receive the 2nd, 3rd or 4th cycle of LMB-100