Table 2. Summarized safety profile for treated patients (n=40).
| HBM4003 0.03 mg/kg (n=1), n (%) | HBM4003 0.1 mg/kg (n=3), n (%) | HBM4003 0.3 mg/kg (n=36), n (%) | Total (n=40), n (%) | |||||
| Any grade | Grade ≥3 | Any grade | Grade ≥3 | Any grade | Grade ≥3 | Any grade | Grade ≥3 | |
| Summary of AEs at different dose levels | ||||||||
| TRAEs | 1 (100.0) | 1 (100.0) | 2 (66.7) | 0 (0.0) | 33 (91.7) | 9 (25.0) | 36 (90.0) | 10 (25.0) |
| Leading to discontinuation of either HBM4003 or toripalimab | 0 | 0 | 0 | 0 | 3 (8.3) | 1 (2.8) | 3 (7.5) | 1 (2.5) |
| All irAEs | 0 | 0 | 0 | 0 | 22 (61.1) | 5 (13.9) | 22 (55.0) | 5 (12.5) |
| Treatment-related SAEs | 0 | 0 | 0 | 0 | 9 (25.0) | 6 (16.7) | 9 (22.5) | 6 (15.0) |
| TRAE lead to death | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| The most common (≥10%) TRAEs | ||||||||
| Rash | 0 | 0 | 0 | 0 | 12 (33.3) | 1 (2.8) | 12 (30.0) | 1 (2.5) |
| Abnormal liver function test* | 0 | 0 | 0 | 0 | 12 (33.3) | 1 (2.8) | 12 (30.0) | 1 (2.5) |
| Leukopenia* | 1 (100.0) | 0 | 1 (33.3) | 0 | 8 (22.2) | 0 | 10 (25.0) | 0 |
| Fever | 0 | 0 | 0 | 0 | 8 (22.2) | 0 | 8 (20.0) | 0 |
| Lymphopenia* | 1 (100.0) | 1 (100.0) | 2 (66.7) | 0 | 5 (13.9) | 1 (2.8) | 8 (20.0) | 2 (5.0) |
| Fatigue* | 0 | 0 | 0 | 0 | 7 (19.4) | 0 | 7 (17.5) | 0 |
| Anemia | 0 | 0 | 0 | 0 | 7 (19.4) | 0 | 7 (17.5) | 0 |
| Diarrhea | 0 | 0 | 0 | 0 | 6 (16.7) | 1 (2.8) | 6 (15.0) | 1 (2.5) |
| Hypothyroidism | 0 | 0 | 0 | 0 | 5 (13.9) | 0 | 5 (12.5) | 0 |
| Neutropenia* | 0 | 0 | 0 | 0 | 4 (11.1) | 0 | 4 (10.0) | 0 |
| Arrhythmia* | 0 | 0 | 0 | 0 | 4 (11.1) | 1 (2.8) | 4 (10.0) | 1 (2.5) |
| Nausea | 0 | 0 | 0 | 0 | 4 (11.1) | 0 | 4 (10.0) | 0 |
| Abnormal test results of thyroid function† | 0 | 0 | 0 | 0 | 4 (11.1) | 0 | 4 (10.0) | 0 |
| Hyperthyroidism | 0 | 0 | 0 | 0 | 4 (11.1) | 0 | 4 (10.0) | 0 |
| Gastroenteritis* | 0 | 0 | 0 | 0 | 4 (11.1) | 1 (2.8) | 4 (10.0) | 1 (2.5) |
| Anorexia | 0 | 0 | 0 | 0 | 4 (11.1) | 0 | 4 (10.0) | 0 |
MedDRA V.version26.0 is used: 26.0.
Pooled preferred terms consisted of the following MedDRA preferred terms: Aabnormal liver function: Aspartate aminotransferase increased, Aalanine aminotransferase increased, Ggamma-glutamyltransferase increased, Bblood alkaline phosphatase increased; Lleukopenia: Lleukopenia, Wwhite blood cell count decreased; Llymphopenia: Llymphocyte percentage decreased, Llymphocyte count decreased; Ffatigue: Ffatigue, Aasthenia, Mmalaise; Nneutropenia: Nneutropenia, Nneutrophil count decreased; Aarrhythmia: Aarrhythmia, Vventricular extrasystoles; Aabnormal test results of thyroid function: Ttri-iodothyronine decreased, Bblood thyroid -stimulating hormone decreased, Bblood thyroid stimulating hormone increased; Ggastroenteritis: Cchronic gastritis, Immune-mediated enterocolitis.
irAE, immune-related adverse event; SAE, severe adverse eventTRAE, treatment-related adverse event