Table 1. Baseline patient characteristics.
| Characteristic | Dose escalation cohorts | Dose expansion cohorts | |||
|---|---|---|---|---|---|
| Overall (n=20) |
MCC (n=13) |
CSCC (n=5) |
Melanoma (n=12) |
SC (n=8) |
|
| Mean age, years (range) | 62.8 (30–86) | 71.9 (56–92) | 61.2 (54–67) | 69.0 (58–78) | 67.8 (41–77) |
| Sex, n (%) | |||||
| Female | 5 (25.0) | 4 (30.8) | 2 (40.0) | 4 (33.3) | 2 (25.0) |
| Male | 15 (75.0) | 9 (69.2) | 3 (60.0) | 8 (66.7) | 6 (75.0) |
| ECOG, n (%) | |||||
| 0 | 9 (45.0) | 6 (46.2) | 0 | 9 (75.0) | 4 (50.0) |
| 1 | 11 (55.0) | 7 (53.8) | 5 (100.0) | 3 (25.0) | 4 (50.0) |
| Race, n (%) | |||||
| White | 20 (100.0) | 12 (92.3) | 5 (100.0) | 11 (91.7) | 8 (100) |
| Tumor type, n (%) | |||||
| Melanoma | 10 (50.0) | 0 | 0 | 12 (100.0) | 3 (37.5) |
| Merkel cell carcinoma | 5 (25.0) | 13 (100.0) | 0 | 0 | 2 (25.0) |
| Cutaneous squamous cell carcinoma | 2 (10.0) | 0 | 5 (100.0) | 0 | 0 |
| Head and neck squamous cell carcinoma | 2 (10.0) | 0 | 0 | 0 | 0 |
| Colon adenocarcinoma | 0 | 0 | 0 | 0 | 2 (25.0) |
| Leiomyosarcoma | 1 (5.0) | 0 | 0 | 0 | 0 |
| Sarcoma | 0 | 0 | 0 | 0 | 1 (12.5) |
| Metastatic disease at screening, n (%) | 19 (95.0) | 12 (92.3) | 3 (60.0) | 12 (100.0) | 8 (100.0) |
| Prior PD-(L)1, n (%) | 19 (95.0) | 13 (100.0) | 5 (100.0) | 12 (100.0) | 8 (100.0) |
| Progressive disease at end of treatment on PD-(L)1, n (%) | 17 (85.0) | 13 (100.0) | 5 (100.0) | 12 (100.0) | 8 (100.0) |
| Prior lines of systemic therapy, n (%) | |||||
| 1 | 7 (35.0) | 8 (61.5) | 3 (60.0) | 2 (25.0) | 2 (16.7) |
| 2 | 5 (25.0) | 3 (23.1) | 0 | 1 (12.5) | 2 (16.7) |
| 3 | 4 (20.0) | 1 (7.7) | 1 (20.0) | 2 (25.0) | 3 (25.0) |
| ≥4 | 4 (20.0) | 1 (7.7) | 1 (20.0) | 3 (37.5) | 5 (41.7) |
CSCC, cutaneous squamous cell carcinoma; ECOG, Eastern Cooperative Oncology Group Performance Status; MCC, Merkel cell carcinoma; PD-(L)1, programmed death-1 / programmed death ligand 1.