Table 2. Exposure.
IT DL1D1 only(n=6) | IT DL2D1, 8, 15, 22(n=3) | IT overall(n=9) | Intravenous DL11-1−1×1011(n=6) | Intravenous DL21-3−3×1012(n=4) | Intravenous DL31-6−6×1012(n=6) | Intravenous overall(n=16) | |
Patients received planned number of doses (n (%)) | 6 (100) | 2 (66.7) | 8 (88.9) | 6 (100) | 3 (75) | 6 (100) | 15 (93) |
Number of doses received (n (%)) | NA | NA | |||||
1 dose | 6 (100) | 0 | 0 | 1 | 0 | ||
2 doses | – | 0 | 0 | 0 | 0 | ||
3 doses | – | 1 | 6 | 3 | 6 | ||
4 doses | – | 2 | – | – | – | ||
Cumulative vp administered (mean (min, max); ×1012 vp) | NA | NA | |||||
Planned | 1.00 | 4.00 | 0.30 | 7.00 | 13.00 | ||
Actual | 0.47 (0.2, 0.8) | 2.67 (1.0, 4.0) | 0.30 (0.30, 0.30) | 5.50 (1.0, 7.0) | 13.00 (13.0, 13.0) |
DL1Dose Level 1DL2Dose Level 2DL3Dose Level 3ITintratumoralvpviral particles