Table 1 Demographics and baseline characteristics of study participants
Cohort 1 (0.1 mg) n = 3 | Cohort 2 (0.5 mg) n = 6 | Cohort 3 (2.5 mg) n = 5 | Cohort 4 (5.0 mg) n = 5 | Cohort 5 (10.0 mg) n = 6 | Overall n = 25 | |
|---|---|---|---|---|---|---|
Age (years) | ||||||
Median | 50.0 | 54.5 | 67.0 | 67.0 | 59.0 | 61.0 |
Range | 47–61 | 37–69 | 63–77 | 47–75 | 48–69 | 37–77 |
Female sex, n (%) | 2 (66.7) | 5 (83.3) | 4 (80.0) | 3 (60.0) | 1 (16.7) | 15 (60.0) |
BMI (kg/m2) | ||||||
Median | 25.2 | 22.1 | 22.3 | 23.3 | 26.2 | 23.4 |
Range | 20.5–32.2 | 16.5–38.0 | 19.9–24.6 | 16.0–31.1 | 19.1–33.3 | 16.0–38.0 |
Race, n (%) | ||||||
Asian | 0 | 1 (16.7) | 0 | 0 | 1 (16.7) | 2 (8.0) |
White | 2 (66.7) | 5 (83.3) | 4 (80.0) | 5 (100) | 5 (83.3) | 21 (84.0) |
Not reported | 1 (33.3) | 0 | 1 (20) | 0 | 0 | 2 (8.0) |
ECOG PS, n (%) | ||||||
0 | 3 (100) | 4 (66.7) | 4 (80.0) | 2 (40.0) | 5 (83.3) | 18 (72.0) |
1 | 0 | 2 (33.3) | 1 (20.0) | 3 (60.0) | 1 (16.7) | 7 (28.0) |
Initial diagnosis, n (%) | ||||||
PDAC | 1 (33.3) | 4 (66.7) | 5 (100) | 4 (80.0) | 6 (100) | 20 (80.0) |
CRC | 2 (66.7) | 2 (33.3) | 0 | 1 (20.0) | 0 | 5 (20.0) |
Disease stage at screening | ||||||
Stage I, II | 1 (33.3) | 2 (33.3) | 3 (60.0) | 1 (20.0) | 1 (16.7) | 8 (32.0) |
Stage III, IVa | 2 (66.7) | 4 (66.7) | 2 (40.0) | 4 (80.0) | 5 (83.3) | 17 (68.0) |
Prior anti-cancer therapy | ||||||
Systemic therapy | 3 (100) | 6 (100) | 5 (100) | 5 (100) | 6 (100) | 25 (100) |
Surgery/procedure | 3 (100) | 6 (100) | 5 (100) | 5 (100) | 6 (100) | 25 (100) |
Radiation therapy | 2 (66.7) | 1 (16.7) | 1 (20.0) | 2 (40.0) | 1 (16.7) | 7 (28.0) |
Tumor KRAS mutation | ||||||
G12 amino acid | DDD | DDDDDD | DRDDD | DDRDD | RRDDRD | |
