Table 1.

Patient demographics and baseline characteristics.

Dose-escalation cohort (N = 15) Dose levelDose-expansion
5 mg/kg10 mg/kg15 mg/kg25 mg/kgcohort (15 mg/kg)All patients
Characteristic(n = 3)(n = 3)(n = 3)(n = 6)(N = 30)(N = 45)
Age, median (range), years63.061.055.062.55960
(59–69)(60–71)(49–67)(53–80)(34–77)(34–80)
Gender, n (%)
 Male3 (100)2 (66.7)03 (50.0)15 (50.0)23 (51.1)
 Female01 (33.3)3 (100)3 (50.0)15 (50.0)22 (48.9)
ECOG PS at baseline
 001 (33.3)0012 (40.0)13 (28.9)
 13 (100.0)2 (66.7)3 (100.0)4 (66.7)16 (53.3)28 (62.2)
 20002 (33.3)2 (6.7)4 (8.9)
Primary tumor type, n (%)
 Adenocarcinoma of gallbladder01 (33.3)0001 (2.2)
 Colon1 (33.3)01 (33.3)3 (50.0)8 (26.7)13 (28.9)
 Esophageal00002 (6.7)2 (4.4)
 Gastric00003 (10.0)3 (6.7)
 Head and neck1 (33.3)00001 (2.2)
 Lung cancer00001 (3.3)1 (2.2)
 Metastatic SCC0001 (16.7)01 (2.2)
 NET00001 (3.3)1 (2.2)
 Non-small cell lung0001 (16.7)5 (16.7)6 (11.3)
 Ovarian002 (66.7)05 (16.7)7 (15.6)
 Rectal01 (33.3)003 (10.0)4 (8.9)
 Renal1 (33.3)1 (33.3)001 (3.3)3 (6.7)
 Thyroid0001 (16.7)01 (2.2)
 Uterine00001 (3.3)1 (2.2)
Median number of prior therapies (range)4 (2–7)3 (2–4)5 (2–7)4 (1–6)3 (1–9)4 (1–9)
  • Abbreviations: ECOG, Eastern Cooperative Oncology Group; NET, neuroendocrine tumor; PS, performance status; SCC, small-cell carcinoma.