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Table 2.

Summary of AEs

Cohort 1Cohort 1ACohort 2Cohort 3ExpansionAll patients
n (%)(N = 3)(N = 3)(N = 3)(N = 3)(N = 27)(N = 39)
Any DLT 
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 
SAE 4 (15) 4 (10)a 
tmt-rel SAE 
Treatment-related AE in ≥2 patients, n (%) Grade 1 Grade 2 Grade ≥3 Any Grade 
Fatigue 12 (31) 7 (18) 19 (49) 
Injection site reactionb 18 (46) 18 (46) 
Myalgia 6 (15) 2 (5) 8 (21) 
Nausea 4 (10) 4 (10) 
Stomatitis 2 (5) 1 (3) 3 (8) 
Headache 3 (8) 3 (8) 
Bilirubin conjugated increased 3 (8) 3 (8) 
Malaise 2 (5) 2 (5) 
Pyrexia 2 (5) 2 (5) 
Diarrhea 2 (5) 2 (5) 
Blood creatinine increased 2 (5) 2 (5) 
Arthralgia 2 (5) 2 (5) 
Paresthesia 2 (5) 2 (5) 
Nasal congestion 2 (5) 2 (5) 
Cohort 1Cohort 1ACohort 2Cohort 3ExpansionAll patients
n (%)(N = 3)(N = 3)(N = 3)(N = 3)(N = 27)(N = 39)
Any DLT 
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 
SAE 4 (15) 4 (10)a 
tmt-rel SAE 
Treatment-related AE in ≥2 patients, n (%) Grade 1 Grade 2 Grade ≥3 Any Grade 
Fatigue 12 (31) 7 (18) 19 (49) 
Injection site reactionb 18 (46) 18 (46) 
Myalgia 6 (15) 2 (5) 8 (21) 
Nausea 4 (10) 4 (10) 
Stomatitis 2 (5) 1 (3) 3 (8) 
Headache 3 (8) 3 (8) 
Bilirubin conjugated increased 3 (8) 3 (8) 
Malaise 2 (5) 2 (5) 
Pyrexia 2 (5) 2 (5) 
Diarrhea 2 (5) 2 (5) 
Blood creatinine increased 2 (5) 2 (5) 
Arthralgia 2 (5) 2 (5) 
Paresthesia 2 (5) 2 (5) 
Nasal congestion 2 (5) 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).

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