Table 1.
Baseline characteristics
| Characteristics | Dose escalation (n = 17) | Dose expansion (N = 40) | ||
|---|---|---|---|---|
| 3 mg/kg (n = 5) | 10 mg/kg (n = 6) | 20 mg/kg (n = 6) | ||
| Median age (range), years | 46 (32–69) | 62 (30–67) | 67 (56–74) | 63 (37–77) |
| < 65 years, n (%) | 3 (60.0) | 5 (83.3) | 2 (33.3) | 22 (55.0) |
| ≥ 65 years, n (%) | 2 (40.0) | 1 (16.7) | 4 (66.7) | 18 (45.0) |
| Sex, n (%) | ||||
| Male | 3 (60.0) | 4 (66.7) | 3 (50.0) | 29 (72.5) |
| Female | 2 (40.0) | 2 (33.3) | 3 (50.0) | 11 (27.5) |
| ECOG performance status, n (%) | ||||
| 0 | 5 (100.0) | 4 (66.7) | 5 (83.3) | 23 (57.5) |
| 1 | 0 | 2 (33.3) | 1 (16.7) | 17 (42.5) |
| Median time since first diagnosis (range), years | 2.9 (1.9–6.1) | 4.5 (1.3–7.7) | 2.9 (1.3–22.3) | 1.5 (0.5–9.1) |
| Median time since diagnosis of metastatic disease (range), years | 1.5 (0.3–6.1) | 3.1 (0.8–7.7) | 2.9 (1.3–14.6) | 1.4 (0.1–8.4) |
| Site of primary tumor, n (%) | ||||
| Breast | 1 (20.0) | 0 | 0 | 0 |
| Choroid | 0 | 0 | 1 (16.7) | 0 |
| Colon | 1 (20.0) | 0 | 0 | 0 |
| Esophagus | 0 | 1 (16.7) | 0 | 0 |
| Gastroesophageal junction | 0 | 0 | 0 | 5 (12.5) |
| Lung | 0 | 2 (33.3) | 1 (16.7) | 0 |
| Nasal cavity | 1 (20.0) | 0 | 0 | 0 |
| Rectum | 0 | 1 (16.7) | 0 | 0 |
| Skin | 2 (40.0) | 0 | 0 | 0 |
| Small intestine | 0 | 0 | 1 (16.7) | 0 |
| Stomach | 0 | 2 (33.3) | 3 (50.0) | 35 (87.5) |
| Number of prior anticancer therapy lines for metastatic or locally advanced disease, n (%) | ||||
| 1 | 1 (20.0) | 0 | 0 | 3 (7.5) |
| 2 | 0 | 1 (16.7) | 1 (16.7) | 14 (35.0) |
| 3 | 2 (40.0) | 3 (50.0) | 2 (33.3) | 14 (35.0) |
| ≥ 4 | 1 (20.0) | 2 (33.3) | 3 (50.0) | 7 (17.5) |
| Missing | 1 (20.0) | 0 | 0 | 2 (5.0) |
| PD-L1 expression (≥ 1% of tumor cells), n (%) | Not assessed | Not assessed | Not assessed | |
| Negative | 27 (67.5) | |||
| Positive | 11 (27.5) | |||
| Not evaluable | 2 (5.0) | |||
ECOG Eastern Cooperative Oncology Group