Table 1.
Baseline characteristics (safety population)
| Part A | Part B | ||||
|---|---|---|---|---|---|
| Sym004 6 mg/kg | Sym004 9/6 mg/kg | Sym004 12 mg/kg | Sym004 18 mg/kg | Sym004 12 mg/kg | |
| Patients, n | 3 | 6 | 6 | 6 | 30 |
| Mean age (years) ± SD | 59.7 ± 3.51 | 62.5 ± 5.09 | 66.5 ± 5.96 | 59.0 ± 9.32 | 61.2 ± 7.2 |
| Male/female | 1/2 | 5/1 | 3/3 | 6/0 | 24/6 |
| ECOG performance status, n | |||||
| 0 | 3 | 5 | 4 | 4 | 16 |
| 1 | 0 | 1 | 2 | 2 | 14 |
| >1 | 0 | 0 | 0 | 0 | 0 |
| Tumor type, n (%) | |||||
| Adenocarcinoma | 2 (66.7) | 4 (66.6) | 4 (66.6) | 5 (83.3) | 0 |
| Squamous cell carcinoma | 1 (33.3) | 2 (33.3) | 2 (33.3) | 0 | 30 (100.0) |
| Other | 0 | 0 | 0 | 1 (16.7) | 0 |
| Prior therapy, n (%) | 3 (100.0) | 6 (100.0) | 6 (100.0) | 6 (100.0) | 30 (100.0) |
| Surgery | 2 (66.7) | 4 (66.7) | 4 (66.7) | 4 (66.7) | 18 (60.0) |
| Radiotherapy | 0 | 1 (16.7) | 1 (16.7) | 2 (33.3) | 21 (70.0) |
| Chemotherapy | 3 (100.0) | 6 (100.0) | 6 (100) | 6 (100.0) | 30 (100.0) |
| Monoclonal antibodya | 2 (66.7) | 3 (50%) | 0 | 2 (33.3) | 0 |
| Protein kinase inhibitorb | 1 (33.3) | 2 (33.3) | 1 (16.7) | 3 (50.0) | 0 |
ECOG, Eastern Cooperative Oncology Group; SD, standard deviation.
a
Monoclonal antibodies included bevicuzumab, cetuximab, panitumumab, ramucirumab, and trastuzumab.
b
Protein kinase inhibitors included erlotinib, gefitinib, regorafenib, and sorafenib.