Table 1.
Patient demographics and characteristics.
| Dose-expansion part II (n = 97) | ||||||||
|---|---|---|---|---|---|---|---|---|
| Characteristic | Dose escalation (n = 34) | Dose-expansion part I (n = 41) | Melanoma (n = 19) | RCC (n = 39) | NSCLC (n = 14) | TNBC (n = 10) | Bladder (n = 15) | All patients with ≥1 treatment (N = 172) |
| Age, y | ||||||||
| Median (range) | 60 (23–88) | 59 (22–81) | 55 (33–72) | 60 (38–88) | 57 (42–81) | 43 (36–66) | 66 (43–82) | 59 (22–88) |
| Sex | ||||||||
| Male, n (%) | 18 (53) | 21 (51) | 11 (58) | 30 (77) | 9 (64) | 0 | 12 (80) | 101 (59) |
| Female, n (%) | 16 (47) | 20 (49) | 8 (42) | 9 (23) | 5 (36) | 10 (100) | 3 (20) | 71 (41) |
| ECOG PS | ||||||||
| 0 | 25 (74) | 20 (49) | 12 (63) | 13 (33) | 6 (43) | 4 (40) | 5 (33) | 85 (49) |
| 1 | 9 (26) | 21 (51) | 7 (37) | 26 (67) | 8 (57) | 6 (60) | 10 (67) | 87 (51) |
| Tumor types (%) | Other (38) | Renal (27) | Cutaneous (58) | Clear cell (100) | Adeno-carcinoma (79) | Ductal (100) | Bladder (60) | |
| Soft tissue sarcoma (15) | Other (24) | Mucosal (11) | Squamous (14) | Renal pelvis (27) | ||||
| CRC (9) | NSCLC (15) | Uveal (16) | Ureter (13) | |||||
| Pancreas (9) | Breast (12) | Unknown (16) | ||||||
| Renal (9) | Pancreas (10) | |||||||
| Breast (6) | CRC (5) | |||||||
| H&N (6) | Sarcoma (5) | |||||||
| NSCLC (6) | H&N (2) | |||||||
| Prior systemic regimen for advanced disease, median (range) | 0 | 1 (1–3) | 3 (1–6) | 1 (1–4) | 1 (1–2) | 1 (1–1) | 1 (1–3) | |
| n (%) for | ||||||||
| aPD1/aPDL1 | 0 | 7 (17) | 18 (95) | 9 (23) | 6 (43) | 1 (10) | 3 (20) | |
| aCTLA4 | 0 | 3 (7) | 14 (74) | 2 (5) | 0 | 0 | 0 | |
| IL2 or IFN | 0 | 3 (7) | 6 (32) | 14 (36) | 0 | 0 | 1 (7) | |