Patient demographics
| Demographic variable | All phase I SA patients (N=134) | All phase I combo patients (N=121) | All phase I patients (N=255) |
| Age, years | |||
| Median | 59.0 | 58.0 | 58.0 |
| Minimum–maximum | 26–81 | 19–77 | 19–81 |
| Sex, n (%) | |||
| Male | 65 (48.5) | 55 (45.5) | 120 (47.1) |
| Female | 69 (51.5) | 66 (54.5) | 135 (52.9) |
| ECOG performance status, n (%) | |||
| 0 | 51 (38.1) | 45 (37.2) | 96 (37.6) |
| 1 | 78 (58.2) | 73 (60.3) | 151 (59.2) |
| 2 | 4 (3.0) | 3 (2.5) | 7 (2.7) |
| Missing | 1 (0.7) | 0 (0) | 1 (0.4) |
| Prior antineoplastic therapies, n | |||
| Median | 3.0 | 3.0 | – |
| Minimum–maximum | 1–11 | 1–14 | – |
| Checkpoint inhibitors (Anti-CTLA-4, PD-1, or PD-L1), n (%) | 51 (38.1) | 22 (18.2) | 73 (28.6) |
| Tumor type (≥2%), n (%) | |||
| Non-small cell lung cancer | 20 (14.9) | 8 (6.6) | 28 (11) |
| Colorectal cancer | 14 (10.4) | 7 (5.8) | 21 (8.2) |
| Cutaneous melanoma | 13 (9.7) | 5 (4.1) | 18 (7.1) |
| Metastatic renal cell carcinoma | 7 (5.2) | 4 (3.3) | 11 (4.3) |
| Sarcoma | 2 (1.5) | 12 (9.9) | 14 (5.5) |
| Ovarian cancer | 7 (5.2) | 7 (5.8) | 14 (5.5) |
| Mesothelioma | 2 (1.5) | 8 (6.6) | 10 (3.9) |
| Bladder cancer | 1 (0.7) | 6 (5.0) | 7 (2.7) |
| Hepatocellular carcinoma | 7 (5.2) | 0 | 7 (2.7) |
| Pancreatic cancer | 1 (0.7) | 6 (5.0) | 7 (2.7) |
| Breast cancer | 5 (3.7) | 3 (2.5) | 8 (3.1) |
| Cervical cancer | 3 (2.2) | 2 (1.7) | 5 (2) |
| Endometrial cancer | 6 (4.5) | 4 (3.3) | 10 (3.9) |
| Malignant neoplasm of thymus | 3 (2.2) | 4 (3.3) | 7 (2.8) |
| Nasopharyngeal cancer | 3 (2.2) | 5 (4.1) | 8 (3.1) |
| Neuroendocrine | 3 (2.2) | 2 (1.7) | 5 (2) |
| Non-cutaneous melanoma | 3 (2.2) | 2 (1.7) | 5 (2) |
| Prostate cancer | 5 (3.7) | 1 (0.8) | 6 (2.4) |
| Head and neck cancer | 4 (3.0) | 5 (4.1) | 9 (3.5) |
| Triple-negative breast cancer | 0 | 5 (4.1) | 5 (2) |
| Other* | 28 (20.9) | 25 (20.7) | 53 (20.8) |
*Other indications included: Basal cell carcinoma, cholangiocarcinoma, esophageal cancer, gallbladder cancer, gastric cancer, gastrointestinal stromal tumor, liposarcoma, small cell lung cancer, small intestine cancer, testicular cancer, and uveal melanoma.
CTLA-4, cytotoxic T-lymphocyte-associated protein 4; ECOG, Eastern Cooperative Oncology Group; PD-1, programmed cell death-1; PD-L1, programmed death-ligand 1; SA, single-agent.