Table 2.
TRAEs, all and of grade 3 or higher, occurring in more than 10% of the overall population
| TRAEs | Dose escalation, n = 42 | Dose expansion RP2D population, n = 50* | PIF/ER population, n = 30† | |||
|---|---|---|---|---|---|---|
| All, n (%) | Grade ≥3, n (%) | All, n (%) | Grade ≥3, n (%) | All, n (%) | Grade ≥3, n (%) | |
| IRR/CRS | 34 (81.0) | 3 (7.1) | 48 (96.0) | 4 (8.0) | 30 (100) | 1 (3.3) |
| Nausea | 11 (26.2) | — | 14 (28.0) | — | 8 (26.7) | — |
| Fatigue | 8 (19.0) | 6 (12.0) | 1 (2.0) | 3 (10.0) | 1 (3.3) | |
| Pyrexia | 8 (19.0) | 2 (4.8) | 11 (22.0) | 6 (20.0) | ||
| Peripheral edema | 6 (14.3) | 15 (30.0) | 1 (2.0) | 8 (26.7) | ||
| Alanine aminotransferase increased | 5 (11.9) | 1 (2.4) | 7 (14.0) | 2 (4.0) | 3 (10.0) | 1 (3.3) |
| Arthralgia | 5 (11.9) | 1 (2.4) | 7 (14.0) | 1 (2.0) | 4 (13.3) | |
| C-reactive protein increased | — | — | 6 (12.0) | 2 (4.0) | — | — |
| Diarrhea | — | — | 11 (22.0) | — | 5 (16.7) | — |
| Hypotension | — | — | 8 (16.0) | — | 4 (13.3) | — |
| Decreased appetite | — | — | 6 (12.0) | 1 (2.0) | 5 (16.7) | 1 (3.3) |
| Tachycardia | — | — | 6 (12.0) | 1 (2.0) | — | — |
| Myalgia | — | — | 8 (16.0) | 2 (4.0) | 4 (13.3) | — |
| Dyspnea | — | — | 9 (18.0) | 3 (6.0) | 4 (13.3) | 2 (6.7) |
| Platelet count decreased | 7 (16.7) | 5 (11.9) | 7 (14.0) | 6 (12.0) | 3 (10.0) | 3 (10.0) |
| Lymphocyte count decreased | 6 (14.3) | 5 (11.9) | 6 (12.0) | 4 (8.0) | ||
| Neutrophil count decreased | 1 (2.4) | 1 (2.4) | 2 (4.0) | 2 (4.0) | 2 (6.7) | 2 (6.7) |
| Treatment-related | 0 | 0 | 1 (2.0) | 1 (2.0) | 1 (3.3) | 1 (3.3) |
| Non–treatment-related | 1 (2.4) | 1 (2.4) | 1 (2.0) | 1 (2.0) | 1 (3.3) | 1 (3.3) |
*
Includes 46 patients treated in expansion cohort and 4 patients treated in dose escalation.
†
A subset of the RP2D patient population.