Table 1.

Baseline demographics and characteristics

CharacteristicsSCC of the Anus, n = 26SCCHN, n = 57sqNSCLC, n = 16All dose expansion cohorts, N = 101a
Median age (range), years58 (31–77)60 (25–76)64 (47–77)60 (25–77)
Sex, n (%)
 Female19 (73)8 (14)7 (44)35 (35)
 Male7 (27)49 (86)9 (56)66 (65)
Race, n (%)
 White24 (92)50 (88)14 (88)90 (89)
 Black or African American0 (0)6 (11)1 (6)7 (7)
 Asian1 (4)1 (2)1 (6)3 (3)
 American Indian or Alaska Native1 (4)0 (0)0 (0)1 (1)
ECOG PS, n (%)
 08 (31)12 (21)4 (25)24 (24)
 118 (69)45 (79)12 (75)77 (76)
Prior therapyb,c, n (%)
 Radiotherapy24 (92)55 (96)14 (88)95 (94)
 Surgery12 (46)40 (70)7 (44)60 (59)
 Systemic regimens
  1–2 regimens15 (58)26 (46)11 (69)52 (51)
  ≥ 3 regimens11 (42)31 (54)5 (31)49 (49)
  • Abbreviations: ECOG PS, Eastern Cooperative Oncology Group performance status; N, population size; n, number of patients in group.

  • aTwo patients, one with SCC of the skin and one with vaginal SCC, were included only in the total dose-expansion population cohort.

  • bPatients may have received more than one prior therapy and so may appear in more than one category.

  • cAll prior therapies are included, not just those received in the metastatic/recurrent setting.