Table 3.
Treatment-related adverse events (TRAEs; any grade in ≥ 10% of patients or grade ≥ 3 in any patient), infusion-related reactions, and immune-related adverse events (AEs; any grade in any patient) in patients with GC/GEJC in the dose-expansion cohort (N = 40)
| N = 40 | Any grade | Grade 3 |
|---|---|---|
| Any TRAE, n (%)a | 32 (80.0) | 3 (7.5) |
| Pruritus | 6 (15.0) | 0 |
| Pyrexia | 5 (12.5) | 0 |
| Rash | 4 (10.0) | 0 |
| Anemia | 2 (5.0) | 1 (2.5) |
| Alanine aminotransferase increased | 1 (2.5) | 1 (2.5) |
| Hyponatraemia | 1 (2.5) | 1 (2.5) |
| Infusion-related reactionb | 12 (30.0) | 0 |
| Any immune-related AE, n (%) | 5 (12.5) | 0 |
| Pruritus | 3 (7.5) | 0 |
| Rash maculopapular | 2 (5.0) | 0 |
| Rash | 1 (2.5) | 0 |
| Hyperthyroidism | 1 (2.5) | 0 |
| Hypothyroidism | 1 (2.5) | 0 |
| Secondary adrenocortical insufficiency | 1 (2.5) | 0 |
No grade ≥ 4 TRAEs occurred
aThe incidence of treatment-related infusion-related reaction based on the single MedDRA preferred term is not listed
bComposite term; includes AEs categorized as infusion-related reaction, drug hypersensitivity, or hypersensitivity reaction that occurred on the day of infusion or day after infusion, in addition to signs and symptoms of infusion-related reaction that occurred on the same day as the infusion and resolved within 2 days (including AEs classified by investigators as related or unrelated to treatment)