Table 1.
Demographic and clinical characteristic of the patients at baseline during dose-escalation and dose-expansion.
| Characteristic | Dose-escalation | Dose-expansion | All (n = 40) | ||||
|---|---|---|---|---|---|---|---|
| 1 mg/kg (n = 1) | 3 mg/kg (n = 6) | 10 mg/kg (n = 6) | 20 mg/kg (n = 3) | 30 mg/kg (n = 6) | 1200 mg (n = 18) | ||
| Median age, years (range) | 62.0 (62–62) | 48.0 (30–61) | 47.5 (37–68) | 52.0 (44–59) | 64.5 (48–67) | 55.0 (33–69) | 54.0 (30–69) |
| Gender (n, %) | |||||||
| Male | 1 (100) | 5 (83.33) | 4 (66.67) | 2 (66.67) | 4 (66.67) | 14 (77.78) | 30 (75.00) |
| Female | 0 | 1 (16.67) | 2 (33.33) | 1 (33.33) | 2 (33.33) | 4 (22.22) | 10 (25.00) |
| ECOG PS (n, %) | |||||||
| 0 | 0 | 0 | 2 (33.33) | 1 (33.33) | 0 | 0 | 3 (7.50) |
| 1 | 1 (100) | 6 (100) | 4 (66.67) | 2 (66.67) | 6 (100) | 18 (100) | 37 (92.50) |
| Concomitant/medical histories (n, %) | |||||||
| No | 1 (100) | 2 (33.33) | 1 (16.67) | 1 (33.33) | 0 | 1 (5.56) | 6 (15.00) |
| Yes | 0 | 4 (66.67) | 5 (83.33) | 2 (66.67) | 6 (100) | 17 (94.44) | 34 (85.00) |
| Previous therapy (n, %) | |||||||
| Surgery | 1 (100) | 5 (83.33) | 3 (50.00) | 3 (100) | 3 (50.00) | 12 (66.67) | 27 (67.50) |
| Chemotherapy | 1 (100) | 5 (83.33) | 6 (100) | 2 (66.67) | 5 (83.33) | 17 (94.44) | 36 (90.00) |
| Radiotherapy | 0 | 5 (83.33) | 4 (66.67) | 1 (33.33) | 2 (33.33) | 12 (66.67) | 24 (60.00) |
| Targeted drugs or immunotherapy | 0 | 2 (33.33) | 2 (33.33) | 1 (33.33) | 4 (66.67) | 5 (27.78) | 14 (35.00) |
| Others anti-tumor therapies | 0 | 1 (16.67) | 4 (66.67) | 2 (66.67) | 1 (16.67) | 7 (38.89) | 15 (37.50) |
| Primary tumor type (n, %) | |||||||
| Nasopharyngeal carcinoma | 0 | 0 | 2 (33.33) | 0 | 0 | 2 (11.11) | 4 (10.00) |
| Lung cancer | 0 | 2 (33.33) | 0 | 0 | 1 (16.67) | 3 (16.67) | 6 (15.00) |
| Hodgkin’s lymphoma | 0 | 1 (16.67) | 1 (16.67) | 0 | 1 (16.67) | 0 | 3 (7.50) |
| Colorectal cancer | 0 | 0 | 1 (16.67) | 1 (33.33) | 2 (33.33) | 3 (16.67) | 7 (17.50) |
| Head and neck tumor | 1 (100) | 1 (16.67) | 1 (16.67) | 1 (33.33) | 0 | 4 (22.22) | 8 (20.00) |
| Other* | 0 | 2 (33.33) | 1 (16.67) | 1 (33.33) | 2 (33.33) | 6 (33.33) | 12 (30.00) |
Others anti-tumor therapies included traditional Chinese medicine and clinical trials of new drugs.
*
Other included non-Hodgkin’s lymphoma (total n = 4; 3 mg/kg, 10 mg/kg, 30 mg/kg, and 1200 mg cohort, n = 1 each), liver cancer (total n = 1; 30 mg/kg cohort, n = 1), cervical cancer (total n = 1; 1200 mg cohort, n = 1), melanoma (total n = 1; 1200 mg cohort, n = 1), squamous cell carcinoma (total n = 1; 1200 mg cohort, n = 1), renal carcinoma (total n = 2; 20 mg/kg, 30 mg/kg, n = 1 each), and gastric cancer (total n = 2; 1200 mg cohort, n = 2).
ECOG PS, Eastern Cooperative Oncology Group performance status.