Table 1.
Patient characteristics.
| Part 1 | Part 2 | Total | ||||||
|---|---|---|---|---|---|---|---|---|
| 5 × 106 | 10 × 106 | 20 × 106 | 40 × 106 | 20 × 106 | 40 × 106 | |||
| Age | 30–59 | 4 | 4 | 2 | 1 | 2 | 2 | 15 |
| ≥60 | 3 | 4 | 4 | 2 | 4 | 1 | 18 | |
| Sex | Male | 3 | 2 | 3 | 2 | 1 | 2 | 13 |
| Female | 4 | 6 | 3 | 1 | 5 | 1 | 20 | |
| Race | African American | 1 | 1 | |||||
| Asian | 2 | 1 | 1 | 4 | ||||
| Caucasian | 7 | 5 | 5 | 3 | 5 | 2 | 27 | |
| Hispanic | 1 | 1 | ||||||
| Primary site of cancer | Breast | 6 | 1 | 7 | ||||
| NSCLC | 1 | 1 | ||||||
| Esophageal/EGJ/stomach | 1 | 1 | 2 | |||||
| Colon/rectal | 2 | 5 | 1 | 1 | 9 | |||
| Ovary | 1 | 2 | 2 | 5 | ||||
| Prostate | 1 | 1 | 2 | |||||
| Bladder, NED a | 2 | 1 | 3 | |||||
| Bladder, metastatic | 2 | 2 | ||||||
| Uterine cervix | 1 | 1 | 2 | |||||
| Previous lines of treatment b | 0–2 | 2 | 3 | 4 | 3 | 2 | 3 | 17 |
| 3 or more | 5 | 5 | 2 | 0 | 4 | 0 | 16 | |
| Total | 7 | 8 | 6 | 3 | 6 | 3 | 33 | |
All patients were ECOG 0 or 1 by eligibility criteria. Part I: n = 24 (no previous HER2-targeted therapy). Part II: n = 9 (previously progressed after one or more HER2-targeted therapy).
a
NED, no evaluable disease; vaccines were given as an adjuvant after the standard care.
b
Number of treatment regimens prior to enrollment, excluding neoadjuvant or adjuvant regimens.