Table 3.
Treatment-Related Adverse Events Occurring in > 10% of Patients
| Dose Escalation | Sequential | Overall | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Cohort 1 | Cohort 2 | Cohort 3 | Cohort 4 | Cohort 5 | Cohort 6 | Cohort 7 | ||||
| Term | 3.5 mg/kg Q2W (N=3) | 7.0 mg/kg Q2W (N=3) | 14.0 mg/kg Q2W (N=5) | 3.0 mg/kg Q4W (N=8) | 5.0 mg/kg Q4W (N=10) | 8.0 mg/kg Q4W (N=9) | 8.0 mg/kg Q4W (N=10) | All Grade (N=48) | Grade 1/2 (N=48) | Grade 3/4 (N=48) |
| Vantictumab-Related AEs | ||||||||||
| Patients with at least one | 2 (66.7%) | 2 (66.7%) | 3 (60%) | 5 (62.5%) | 7 (70%) | 6 (66.7%) | 4 (40%) | 29 (60.4%) | 24 (50.0%) | 5 (10.4%)* |
| Fatigue | 0 | 0 | 2 (40%) | 3 (37.5%) | 1 (10%) | 5 (55.6%) | 1 (10%) | 12 (25%) | 12 (25%) | 0 |
| Nausea | 1 (33.3%) | 0 | 0 | 3 (37.5%) | 2 (20%) | 3 (33.3%) | 2 (20%) | 11 (22.9%) | 11 (22.9%) | 0 |
| Constipation | 1 (33.3%) | 1 (33.3%) | 2 (40%) | 1 (12.5%) | 2 (20%) | 0 | 1 (10%) | 8 (16.7%) | 8 (16.7%) | 0 |
| Diarrhea | 0 | 1 (33.3%) | 0 | 4 (50%) | 0 | 0 | 0 | 5 (10.4%) | 5 (10.4%) | 0 |
| Any Study Treatment-Related AEs | ||||||||||
| Patients with at least one | 3 (100%) | 3 (100%) | 3 (60%) | 6 (75%) | 10 (100%) | 9 (100%) | 10 (100%) | 44 (91.7%) | 25 (52.1%) | 19 (39.5%) |
| Nausea | 1 (33.3%) | 1 (33.3%) | 1 (20%) | 6 (75%) | 5 (50%) | 5 (55.6%) | 7 (70%) | 26 (54.2%) | 25 (52.1%) | 1 (2.1%) |
| Alopecia | 1 (33.3%) | 2 (66.7%) | 2 (40%) | 3 (37.5%) | 6 (60%) | 7 (77.8%) | 4 (40%) | 25 (52.1%) | 24 (50.0%) | 1 (2.1%) |
| Fatigue | 1 (33.3%) | 0 | 2 (40%) | 4 (50%) | 3 (30%) | 6 (66.7%) | 7 (70%) | 23 (47.9%) | 23 (47.9%) | 0 |
| Neuropathy peripheral | 3 (100%) | 1 (33.3%) | 2 (40%) | 2 (25%) | 7 (70%) | 4 (44.4%) | 2 (20%) | 21 (43.8%) | 18 (37.5%) | 3 (6.3%) |
| Neutropenia | 0 | 2 (66.7%) | 1 (20%) | 3 (37.5%) | 3 (30%) | 3 (33.3%) | 3 (30%) | 15 (31.3%) | 5 (10.4%) | 10 (20.1%) |
| Constipation | 1 (33.3%) | 1 (33.3%) | 2 (40%) | 2 (25%) | 4 (40%) | 2 (22.2%) | 2 (20%) | 14 (29.2%) | 14 (29.2%) | 0 |
| Anemia | 1 (33.3%) | 0 | 1 (20%) | 2 (25%) | 2 (20%) | 3 (33.3%) | 3 (30%) | 12 (25%) | 11 (22.9%) | 1 (2.1%) |
| Diarrhea | 2 (66.7%) | 1 (33.3%) | 0 | 5 (62.5%) | 1 (10%) | 0 | 2 (20%) | 11 (22.9%) | 11 (22.9%) | 0 |
| Myalgia | 1 (33.3%) | 0 | 0 | 1 (12.5%) | 4 (40%) | 1 (11.1%) | 3 (30%) | 10 (20.8%) | 10 (20.8%) | 0 |
| Peripheral sensory neuropathy | 0 | 0 | 0 | 1 (12.5%) | 0 | 1 (11.1%) | 6 (60%) | 8 (16.7%) | 7 (14.6%) | 1 (2.1%) |
| Decreased appetite | 0 | 1 (33.3%) | 0 | 2 (25%) | 1 (10%) | 2 (22.2%) | 1 (10%) | 7 (14.6%) | 7 (14.6%) | 0 |
| Dysgeusia | 0 | 0 | 0 | 1 (12.5%) | 1 (10%) | 2 (22.2%) | 3 (30%) | 7 (14.6%) | 7 (14.6%) | 0 |
| Gastroesophageal reflux | 1 (33.3%) | 0 | 0 | 2 (25%) | 2 (20%) | 1 (11.1%) | 1 (10%) | 7 (14.6%) | 7 (14.6%) | 0 |
| Rash | 0 | 0 | 0 | 1 (12.5%) | 12 (20%) | 1 (11.1%) | 2 (20%) | 6 (12.5%) | 6 (12.5%) | 0 |
| Stomatitis | 0 | 1 (33.3%) | 0 | 2 (25%) | 1 (10%) | 2 (22.2%) | 0 | 6 (12.5%) | 6 (12.5%) | 0 |
| Vomiting | 0 | 0 | 0 | 2 (25%) | 2 (20%) | 1 (11.1%) | 1 (10%) | 6 (12.5%) | 5 (10.4%) | 1 (2.1%) |
| Arthralgia | 0 | 0 | 0 | 1 (12.5%) | 0 | 1 (11.1%) | 3 (30%) | 5 (10.4%) | 4 (8.3%) | 1 (2.1%) |
| Chills | 0 | 0 | 0 | 1 (12.5%) | 2 (20%) | 0 | 2 (20%) | 5 (10.4%) | 5 (10.4%) | 0 |
*
No ≥ grade 4 vantictumab-related AEs were observed