Table 1.

Baseline and disease characteristics of patients with MBC and NSCLC treated at the RP2D of 2.4 mg/kg and all patients on treatment (0.2–2.4 mg/kg).

2.4 mg/kg2.4 mg/kgAll patients
VariableMBC (n = 29)NSCLC (n = 25)(N = 68)
Age (years) median546358
 (range)(33–71)(45–82)(33–82)
Gender, n (%)
 Male1 (3)12 (48)13 (19)
 Female28 (97)13 (52)55 (81)
ECOG status, n (%)
 017 (59)4 (16)23 (34)
 112 (41)21 (84)45 (66)
Median time (months) between initial diagnosis and metastatic diseasea31.50.28
 (range)(0–256.3)(0–35.2)(0–256.3)
NSCLC histology
 Squamous-8 (32)8 (32)
 Nonsquamous-17 (68)17 (68)
Breast cancer histology
 HR+, HER2−21 (72)-24 (69)
 TNBC8 (28)-11 (31)
Median prior lines of hormone therapy in HR+, HER2− MBC (adv/met)b3--
 (range)(0–4)--
Cytotoxic regimen (adv/met)
 Prior platinum (≥1)9 (31)25 (100)43 (63)
 Prior taxane (≥1)26 (90)16 (64)53 (78)
Prior immunotherapy (≥1)2 (7)22 (88)24 (35)
  • aOne patient in the MBC group had no metastatic date available, and one patient in the dose-escalation group had no initial diagnosis date available.

  • bRepresents the median number of lines of hormonal therapy in the advanced/metastatic setting for the 21 patients with HR+, HER2− patients treated at 2.4 mg/kg. See Supplementary Table S1 for demographic data for remaining patients who participated in the dose-escalation group.