Table 1.
Patient Characteristics
| All Patients in Safety Population | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| Part A (n = 23) | Part B (n = 34) | Total (N = 57) | |||||||
| Characteristic | No. | % | No. | % | No. | % | |||
| Sex | |||||||||
| Male | 13 | 56.5 | 20 | 58.8 | 33 | 57.9 | |||
| Female | 10 | 43.5 | 14 | 41.2 | 24 | 42.1 | |||
| Age, years | |||||||||
| Median | 58 | 60 | 59 | ||||||
| Range | 29–78 | 34–84 | 29–84 | ||||||
| Race | |||||||||
| White | 21 | 91.3 | 33 | 97.1 | 54 | 94.7 | |||
| African American | 1 | 4.3 | 1 | 2.9 | 2 | 3.5 | |||
| Asian | 1 | 4.3 | 0 | 0 | 1 | 1.8 | |||
| ECOG performance status at screening | |||||||||
| 0 | 9 | 39.1 | 13 | 38.2 | 22 | 38.6 | |||
| 1 | 14 | 60.9 | 20 | 58.8 | 34 | 59.6 | |||
| 2 | 0 | 0 | 1 | 2.9 | 1 | 1.8 | |||
| No. of metastatic sites | |||||||||
| 1 | 6 | 26.1 | 6 | 17.6 | 12 | 21.1 | |||
| 2 | 39.1 | 26.5 | 18 | 31.6 | |||||
| ≥ 3 | 8 | 34.8 | 19 | 55.9 | 27 | 47.3 | |||
| Prior anticancer treatments | |||||||||
| Surgery | 21 | 91.3 | 32 | 94.1 | 53 | 93.0 | |||
| Radiation | 13 | 56.5 | 25 | 73.5 | 38 | 66.7 | |||
| Chemotherapy regimens | 22 | 95.7 | 30 | 88.2 | 52 | 91.2 | |||
| 0 | 1 | 4.3 | 4 | 11.8 | 5 | 8.8 | |||
| 1 | 7 | 30.4 | 6 | 17.6 | 13 | 22.8 | |||
| ≥ 2 | 15 | 65.2 | 24 | 70.6 | 39 | 68.4 | |||
| Cancer types | |||||||||
| Melanoma | 20 | 35.1 | |||||||
| Breast | 10 | 17.5 | |||||||
| Colorectal | 5 | 8.8 | |||||||
| Other* | 22 | 38.6 | |||||||
Abbreviation: ECOG, Eastern Cooperative Oncology Group.
*
Two patients each: non–small-cell lung cancer, hepatocellular, head and neck, sarcoma, thyroid, gastroesophageal junction; one each: lung squamous cell carcinoma, adenoid cystic, mesothelioma, renal cell, pancreatic, ovarian, bronchoalveolar, bladder, thymus, and leiomyosarcoma.