Summary of AEs
| . | Cohort 1 . | Cohort 1A . | Cohort 2 . | Cohort 3 . | Expansion . | All patients . |
|---|---|---|---|---|---|---|
| n (%) . | (N = 3) . | (N = 3) . | (N = 3) . | (N = 3) . | (N = 27) . | (N = 39) . |
| Any DLT | 0 | 0 | 0 | 0 | 0 | 0 |
| Any AE | 3 (100) | 3 (100) | 3 (100) | 3 (100) | 27 (100) | 39 (100) |
| Any tmt-rel AE | 3 (100) | 3 (100) | 3 (100) | 3 (100) | 22 (81) | 34 (87) |
| Grade ≥3 tmt-rel AE | 0 | 0 | 0 | 0 | 0 | 0 |
| SAE | 0 | 0 | 0 | 0 | 4 (15) | 4 (10)a |
| tmt-rel SAE | 0 | 0 | 0 | 0 | 0 | 0 |
| Treatment-related AE in ≥2 patients, n (%) | Grade 1 | Grade 2 | Grade ≥3 | Any Grade | ||
| Fatigue | 12 (31) | 7 (18) | 0 | 19 (49) | ||
| Injection site reactionb | 18 (46) | 0 | 0 | 18 (46) | ||
| Myalgia | 6 (15) | 2 (5) | 0 | 8 (21) | ||
| Nausea | 4 (10) | 0 | 0 | 4 (10) | ||
| Stomatitis | 2 (5) | 1 (3) | 0 | 3 (8) | ||
| Headache | 3 (8) | 0 | 0 | 3 (8) | ||
| Bilirubin conjugated increased | 3 (8) | 0 | 0 | 3 (8) | ||
| Malaise | 2 (5) | 0 | 0 | 2 (5) | ||
| Pyrexia | 2 (5) | 0 | 0 | 2 (5) | ||
| Diarrhea | 2 (5) | 0 | 0 | 2 (5) | ||
| Blood creatinine increased | 2 (5) | 0 | 0 | 2 (5) | ||
| Arthralgia | 2 (5) | 0 | 0 | 2 (5) | ||
| Paresthesia | 2 (5) | 0 | 0 | 2 (5) | ||
| Nasal congestion | 2 (5) | 0 | 0 | 2 (5) | ||
| . | Cohort 1 . | Cohort 1A . | Cohort 2 . | Cohort 3 . | Expansion . | All patients . |
|---|---|---|---|---|---|---|
| n (%) . | (N = 3) . | (N = 3) . | (N = 3) . | (N = 3) . | (N = 27) . | (N = 39) . |
| Any DLT | 0 | 0 | 0 | 0 | 0 | 0 |
| Any AE | 3 (100) | 3 (100) | 3 (100) | 3 (100) | 27 (100) | 39 (100) |
| Any tmt-rel AE | 3 (100) | 3 (100) | 3 (100) | 3 (100) | 22 (81) | 34 (87) |
| Grade ≥3 tmt-rel AE | 0 | 0 | 0 | 0 | 0 | 0 |
| SAE | 0 | 0 | 0 | 0 | 4 (15) | 4 (10)a |
| tmt-rel SAE | 0 | 0 | 0 | 0 | 0 | 0 |
| Treatment-related AE in ≥2 patients, n (%) | Grade 1 | Grade 2 | Grade ≥3 | Any Grade | ||
| Fatigue | 12 (31) | 7 (18) | 0 | 19 (49) | ||
| Injection site reactionb | 18 (46) | 0 | 0 | 18 (46) | ||
| Myalgia | 6 (15) | 2 (5) | 0 | 8 (21) | ||
| Nausea | 4 (10) | 0 | 0 | 4 (10) | ||
| Stomatitis | 2 (5) | 1 (3) | 0 | 3 (8) | ||
| Headache | 3 (8) | 0 | 0 | 3 (8) | ||
| Bilirubin conjugated increased | 3 (8) | 0 | 0 | 3 (8) | ||
| Malaise | 2 (5) | 0 | 0 | 2 (5) | ||
| Pyrexia | 2 (5) | 0 | 0 | 2 (5) | ||
| Diarrhea | 2 (5) | 0 | 0 | 2 (5) | ||
| Blood creatinine increased | 2 (5) | 0 | 0 | 2 (5) | ||
| Arthralgia | 2 (5) | 0 | 0 | 2 (5) | ||
| Paresthesia | 2 (5) | 0 | 0 | 2 (5) | ||
| Nasal congestion | 2 (5) | 0 | 0 | 2 (5) | ||
Abbreviation: Tmt-rel, treatment-related.
aSAEs were grade 3 small intestinal obstruction (n = 2), grade 3 abdominal pain, and grade 3 hypoxia.
bNumber of unique patients who experienced one or more of the following AE: injection site pruritus (n = 10 patients), injection site reaction (n = 7 patients), injection site pain (n = 5 patients), and injection site erythema (n = 4 patients).