Table 2.

DLTs and treatment-related adverse events

Patients reporting DLTs or AEs, n (%)AMG 102 dose cohort (mg/kg)
0.5 (n = 7)1 (n = 7)3 (n = 4)5 (n = 4)10 (n = 5)20 (n = 13)*Total (N = 40)
DLTs
    Hypoxia, grade 31 (14)0 (0)0 (0)0 (0)0 (0)0 (0)1 (3)
    Exacerbated dyspnea, grade 31 (14)0 (0)0 (0)0 (0)0 (0)0 (0)1 (3)
    Upper gastrointestinal hemorrhage, grade 30 (0)1 (14)0 (0)0 (0)0 (0)0 (0)1 (3)
All treatment-related AEs5 (71)4 (57)1 (25)3 (75)1 (20)5 (38)19 (48)
Gastrointestinal disorders
    Constipation1 (14)0 (0)0 (0)1(25)0 (0)1 (8)3 (8)
        Grade 11 (14)0 (0)0 (0)1 (25)0 (0)0 (0)2 (5)
        Grade 20 (0)0 (0)0 (0)0 (0)0 (0)1 (8)1 (3)
    Nausea1 (14)0 (0)0 (0)1 (25)0 (0)1 (8)3 (8)
        Grade 11 (14)0 (0)0 (0)1 (25)0 (0)1 (8)3 (8)
    Vomiting0 (0)1 (14)0 (0)0 (0)0 (0)1 (8)2 (5)
        Grade 10 (0)0 (0)0 (0)0 (0)0 (0)1 (8)1 (3)
        Grade 20 (0)1 (14)0 (0)0 (0)0 (0)0 (0)1 (3)
General disorders and administration site conditions
    Fatigue2 (29)1 (14)0 (0)1 (25)1 (20)0 (0)5 (13)
        Grade 11 (14)0 (0)0 (0)1 (25)0 (0)0 (0)2 (5)
        Grade 21 (14)1 (14)0 (0)0 (0)1 (20)0 (0)3 (8)
Metabolism and nutrition disorders
    Anorexia/decreased appetite1 (14)0 (0)0 (0)1 (25)0 (0)1 (8)3 (8)
        Grade 11 (14)0 (0)0 (0)1 (25)0 (0)1 (8)3 (8)
Musculoskeletal and connective tissue disorders
    Myalgia1 (14)0 (0)0 (0)0 (0)0 (0)1 (8)2 (5)
        Grade 11 (14)0 (0)0 (0)0 (0)0 (0)1 (8)2 (5)
Vascular disorders
    Hypotension0 (0)2 (29)0 (0)0 (0)0 (0)0 (0)2 (5)
        Grade 10 (0)2 (29)0 (0)0 (0)0 (0)0 (0)2 (5)
Treatment-related AEs with a worst grade ≥3
    Colonic fistula, grade 30 (0)0 (0)0 (0)0 (0)0 (0)1 (8)1 (3)
    Dyspnea exacerbated, grade 31 (14)0 (0)0 (0)0 (0)0 (0)0 (0)1 (3)
    Hypoxia, grade 31 (14)0 (0)0 (0)0 (0)0 (0)0 (0)1 (3)
    Upper gastrointestinal hemorrhage, grade 30 (0)1 (14)0 (0)0 (0)0 (0)0 (0)1 (3)

NOTE: Adverse events occurring in ≥5% of patients and adverse events with a worst grade ≥3 are shown. Safety analysis set includes patients who received one or more dose of AMG 102.

Abbreviation: AEs, adverse events.

  • *Includes patients from both dose escalation and dose expansion.

  • Hypoxia and exacerbated dyspnea occurred in the same patient.