Table 2. Summary of the most common treatment-emergent adverse events occurring in ≥ 10% of all patients.
TEAE, n (%) | Dose-escalation cohort Dose, mg/m2 | Dose-expansion cohort | Total (N = 38) | ||||
---|---|---|---|---|---|---|---|
260 (N = 6) | 340 (N = 4) | 440 (N = 3) | 570 (N = 6) | All (N = 19) | GC (N = 14) | ||
Nausea | 1 (16.7) | 2 (50) | 0 (0) | 3 (50) | 8 (42.1) | 4 (28.6) | 14 (36.8) |
Vomiting | 1 (16.7) | 1 (25.0) | 0 (0) | 1 (16.7) | 10 (52.6) | 6 (42.9) | 13 (34.2) |
Decreased appetite | 1 (16.7) | 1 (25.0) | 1 (33.3) | 0 (0) | 8 (42.1) | 5 (35.7) | 11 (28.9) |
Constipation | 2 (33.3) | 0 (0) | 1 (33.3) | 1 (16.7) | 4 (21.1) | 2 (14.3) | 8 (21.1) |
Fatigue/asthenia | 3 (50) | 0 (0) | 1 (33.3) | 0 (0) | 4 (21.1) | 2 (14.3) | 8 (21.1) |
Abdominal pains | 1 (16.7) | 0 (0) | 1 (33.3) | 0 (0) | 6 (31.5) | 2 (14.3) | 8 (21.1) |
Pyrexia | 4 (66.7) | 0 (0) | 0 (0) | 0 (0) | 3 (15.8) | 1 (7.1) | 7 (18.4) |
Injection site reaction/phlebitis | 1 (16.7) | 0 (0) | 0 (0) | 1 (16.7) | 5 (26.3) | 4 (28.6) | 7 (18.4) |
Back pain | 3 (50.0) | 0 (0) | 0 (0) | 0 (0) | 2 (10.5) | 2 (14.3) | 5 (13.2) |
Diarrhea | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 5 (26.3) | 4 (28.6) | 5 (13.2) |
Cancer pain | 0 (0) | 0 (0) | 1 (33.3) | 2 (33.3) | 1 (5.3) | 1 (7.1) | 4 (10.5) |
Edema, peripheral | 0 (0) | 0 (0) | 0 (0) | 1 (16.7) | 3 (15.8) | 2 (14.3) | 4 (10.5) |
Insomnia | 1 (16.7) | 0 (0) | 0 (0) | 0 (0) | 3 (15.8) | 2 (14.3) | 4 (10.5) |
Rash | 2 (33.3) | 1 (25.0) | 0 (0) | 0 (0) | 1 (5.3) | 1 (7.1) | 4 (10.5) |
Cough | 2 (33.3) | 1 (25.0) | 0 (0) | 0 (0) | 1 (5.3) | 1 (7.1) | 4 (10.5) |
GC, gastric cancer; TEAE, treatment-emergent adverse events.