Table 1 Baseline characteristics of BPI-9016M treated patients
Characteristics | Part A | Part B | Total (n = 38) | ||
|---|---|---|---|---|---|
300 mg QD (n = 12) | 450 mg QD (n = 12) | 600 mg QD (n = 10) | 400 mg BID (n = 4) | ||
Age (years), median (range) | 60.0 (47–78) | 61.5 (50–66) | 57.0 (52–65) | 67.0 (67–76) | 60.0 (47–78) |
Sex, n (%) | |||||
 Male | 8 (66.7) | 4 (33.3) | 7 (70.0) | 1 (25.0) | 20 (52.6) |
 Female | 4 (33.3) | 8 (66.7) | 3 (30.0) | 3 (75.0) | 18 (47.4) |
ECOG PS, n (%) | |||||
 0 | 4 (33.3) | 3 (25.0) | 2 (20.0) | 0 | 9 (23.7) |
 1 | 8 (66.7) | 9 (75.0) | 8 (80.0) | 4 (100.0) | 29 (76.3) |
Tumor histology, n (%) | |||||
 Adenocarcinoma | 11 (91.7) | 12 (100.0) | 9 (90.0) | 4 (100.0) | 36 (94.7) |
 Squamous cell carcinoma | 0 | 0 | 1 (10.0) | 0 | 1 (2.6) |
 Poorly-differentiated carcinoma | 1 (8.3) | 0 | 0 | 0 | 1 (2.6) |
Stage, n (%) | |||||
 IIIB | 1 (8.3) | 1 (8.3) | 1 (10.0) | 0 | 3 (7.9) |
 IV | 11 (91.7) | 11 (91.7) | 9 (90.0) | 4 (100.0) | 35 (92.1) |
c-MET/MET alteration status, n (%) | |||||
 c-MET overexpression | 12 (100.0) | 12 (100.0) | 10 (100.0) | NE | 34 (89.5) |
 MET exon 14 skipping mutation | NE | NE | NE | 4 (100.0) | 4 (10.5) |
Number of metastatic lesions, n (%) | |||||
  < 3 | 5 (41.7) | 5 (41.7) | 4 (40.0) | 2 (50.0) | 16 (42.1) |
  ≥ 3 | 7 (58.3) | 7 (58.3) | 6 (60.0) | 2 (50.0) | 22 (57.9) |
Prior treatment, n (%) | |||||
 Surgery | 1 (8.3) | 4 (33.3) | 4 (40.0) | 1 (25.0) | 10 (26.3) |
 Radiotherapy | 4 (33.3) | 4 (33.3) | 0 | 1 (25.0) | 9 (23.7) |
 Chemotherapy or targeted therapy | 12 (100.0) | 12 (100.0) | 10 (100.0) | 3 (75.0) | 37 (97.4) |
 Others | 1 (8.3) | 0 | 0 | 0 | 1 (2.6) |
Prior lines of systemic therapy, n (%) | |||||
 0 | 0 | 0 | 0 | 1 (25.0) | 1 (2.6) |
 1 | 3 (25.0) | 2 (16.7) | 1 (10.0) | 0 | 6 (15.8) |
 2 | 5 (41.7) | 3 (25.0) | 5 (50.0) | 2 (50.0) | 15 (39.5) |
 3 | 2 (16.7) | 3 (25.0) | 2 (20.0) | 0 | 7 (18.4) |
 4 | 2 (16.7) | 3 (25.0) | 1 (10.0) | 1 (25.0) | 7 (18.4) |
  ≥ 5 | 0 | 1 (8.3) | 1 (10.0) | 0 | 2 (5.3) |