Table 1.
Baseline demographics and characteristics
| Characteristics | Treatment group (dose level) | |||||||
| 7 mg (n=4) |
20 mg (n=4) |
70 mg (n=22) |
200 mg (n=18) |
350 mg (n=23) |
700 mg (n=12) |
1400 mg (n=4) |
Total (N=87) |
|
| Median age, years (range) | 58 (32–69) | 67 (47–74) | 56 (27–78) | 61 (25–79) | 60 (35–78) | 62 (37–73) | 56 (20–79) | 60 (20–79) |
| Sex, n (%) | ||||||||
| Female | 2 (50.0) | 3 (75.0) | 14 (63.6) | 12 (66.7) | 17 (73.9) | 3 (25.0) | 2 (50.0) | 53 (60.9) |
| Male | 2 (50.0) | 1 (25.0) | 8 (36.4) | 6 (33.3) | 6 (26.1) | 9 (75.0) | 2 (50.0) | 34 (39.1) |
| Race, n (%) | ||||||||
| White | 4 (100) | 3 (75.0) | 19 (86.4) | 17 (94.4) | 23 (100) | 9 (75.0) | 4 (100) | 79 (90.8) |
| Other | 0 | 1 (25.0) | 3 (13.6) | 1 (5.6) | 0 | 3 (25.0) | 0 | 8 (9.2) |
| Tumor type, n (%) | ||||||||
| Colorectal cancer | 3 (75.0) | 0 (0.0) | 1 (4.5) | 3 (16.7) | 6 (26.1) | 1 (8.3) | 1 (25.0) | 15 (17.2) |
| Ovarian | 0 | 0 | 3 (13.6) | 2 (11.1) | 1 (4.3) | 1 (8.3) | 0 | 7 (8.0) |
| Non-small cell lung cancer | 0 | 1 (25.0) | 2 (9.1) | 1 (5.6) | 1 (4.3) | 1 (8.3) | 0 | 6 (6.9) |
| Melanoma | 0 | 0 | 1 (4.5) | 2 (11.1) | 2 (8.7) | 0 | 0 | 5 (5.7) |
| Pancreatic cancer | 0 | 1 (25.0) | 0 | 0 | 3 (13.0) | 1 (8.3) | 0 | 5 (5.7) |
| Anal cancer | 0 | 0 | 1 (4.5) | 0 (0.0) | 0 (0.0) | 1 (8.3) | 2 (50.0) | 4 (4.6) |
| Head and neck cancer | 0 | 0 | 1 (4.5) | 1 (5.6) | 1 (4.3) | 1 (8.3) | 0 (0.0) | 4 (4.6) |
| Sarcoma | 0 | 0 | 2 (9.1) | 1 (5.6) | 0 | 0 | 1 (25.0) | 4 (4.6) |
| Other solid tumors* | 1 (25.0) | 2 (50.0) | 11 (50.0) | 8 (44.4) | 9 (39.1) | 6 (50.0) | 0 | 37 (42.5) |
| Received prior therapy, n (%) | 4 (100) | 4 (100) | 21 (95.5) | 18 (100) | 23 (100) | 11 (91.7) | 4 (100) | 85 (97.7) |
| Advanced/metastatic regimen | 4 (100) | 4 (100) | 21 (95.5) | 18 (100) | 21 (91.3) | 11 (91.7) | 4 (100) | 83 (95.4) |
| Surgery | 4 (100) | 2 (50.0) | 18 (81.8) | 15 (83.3) | 17 (73.9) | 9 (75.0) | 3 (75.0) | 68 (78.2) |
| Radiotherapy | 2 (50.0) | 1 (25.0) | 13 (59.1) | 10 (55.6) | 10 (43.5) | 8 (66.7) | 4 (100) | 48 (55.2) |
| Immunotherapy† | 0 | 2 (50.0) | 6 (27.3) | 7 (38.9) | 7 (30.4) | 2 (16.7) | 0 | 24 (27.6) |
*Mesothelioma (three patients, 3.4%); bladder, breast, cervical, endometrial, esophageal, gallbladder, hepatocellular, neuroendocrine, and testicular (two patients, 2.3% each); adrenal, chordoma, gastroesophageal, renal, salivary gland, and uterine (one patient, 1.1% each); other cancers (10 patients, 11.5%).
†Twenty-three patients (26.4%) received immunotherapy that included PD-1/PD-L1 therapy; one patient (1.1%) in the 20 mg cohort received antivascular endothelial growth factor receptor-2 (ramucirumab) immunotherapy (did not receive any PD-1/PD-L1 therapy).
PD-1, programmed cell death protein 1; PD-L1, programmed death-ligand 1.