Table 1. Baseline demographics and disease characteristics.
| Characteristic | IT DL1D1 only(n=6) | IT DL2D1, 8, 15, 22(n=3) | IT overall(n=9) | Intravenous DL11×1011(n=6) | Intravenous DL21-3−3×1012(n=4) | Intravenous DL31-6−6×1012(n=6) | Intravenous overall(n=16) |
| Median age, years (min, max) | 57.5 (36, 69) | 54 (51, 72) | 54 (36, 72) | 56 (47, 63) | 53 (32, 75) | 55 (50, 78) | 55 (32, 78) |
| Male, n (%) | 3 (50.0) | 3 (100) | 6 (66.7) | 4 (66.7) | 1 (25.0) | 1 (16.7) | 6 (37.5) |
| Race, n (%) | |||||||
| White | 4 (66.7) | 1 (33.3) | 5 (55.6) | 3 (50.0) | 4 (100) | 5 (83.3) | 12 (75.0) |
| Asian | 2 (33.3) | 1 (33.3) | 3 (33.3) | 1 (16.7) | 0 | 1 (16.7) | 2 (12.5) |
| Other | 0 | 1 (33.3) | 1 (11.1) | 2 (33.3) | 0 | 0 | 2 (12.5) |
| Tumor type, n (%) | |||||||
| CRC | 3 (50.0) | 1 (33.3) | 4 (44.4) | 0 | 1 (25.0) | 3 (50.0) | 4 (25.0) |
| SCCHN | 0 | 0 | 0 | 2 (33.3) | 1 (25.0) | 1 (16.7) | 4 (25.0) |
| Pancreatic cancer | 0 | 1 (33.3) | 1 (11.1) | 1 (16.7) | 2 (50.0) | 0 | 3 (18.8) |
| Esophageal/GEJ cancer | 0 | 1 (33.3) | 1 (11.1) | 1 (16.7) | 0 | 1 (16.7) | 2 (12.5) |
| Cholangiocarcinoma | 2 (33.3) | 0 | 2 (22.2) | 1 (16.7) | 0 | 0 | 1 (6.3) |
| Other* | 1 (16.7) | 0 | 1 (11.1) | 1 (16.7) | 0 | 1 (16.7) | 2 (12.5) |
| Median time from diagnosis, months (min, max) | 22 (13, 30) | 37 (16, 46) | 22 (13, 46) | 52 (21, 178) | 35 (23, 47) | 47 (16, 87) | 42 (16, 178) |
| Prior cancer therapies, n (%) | 6 (100) | 3 (100) | 9 (100) | 6 (100) | 4 (100) | 6 (100) | 16 (100) |
| 1–2 prior lines | 2 (33.3) | 1 (33.3) | 3 (33.3) | 3 (50.0) | 2 (50.0) | 2 (33.3) | 7 (43.8) |
| 3+lines | 4 (66.7) | 2 (66.7) | 6 (66.7) | 3 (50.0) | 2 (50.0) | 4 (66.7) | 9 (56.7) |
| Prior antineoplastic agents | 6 (100) | 2 (66.7) | 8 (88.9) | 6 (100) | 4 (100) | 6 (100) | 16 (100) |
| Prior radiotherapy | 1 (16.7) | 2 (66.7) | 3 (33.3) | 6 (100) | 1 (25.0) | 3 (50.0) | 10 (62.5) |
| Prior cancer surgery | 4 (66.7) | 3 (100) | 7 (77.8) | 6 (100) | 4 (100) | 4 (66.7) | 14 (87.5) |
*
Includes breast cancer, cervical cancer, and prostate cancer.
†
CRC, colorectal cancer; SCCHN, squamous cell carcinoma of head and neck; GEJ, gastroesophageal junction.
DL1Dose Level 1DL2Dose Level 2DL3Dose Level 3ITintratumoral