Table 1.
Patient Demographic and Clinical Characteristics
| Patient by Cohort | Characteristic |
|||||||
|---|---|---|---|---|---|---|---|---|
| Age (years) | Sex | Malignancy | ECOG PS | Metastatic Site | Prior Chemotherapy | Clinical Benefit | HER2 Positivity Status | |
| Cohort 1:1A | 73 | F | Colon | 0 | Lung | 2 | +SD | — |
| 1B | 75 | F | SCC | 0 | Thigh | 2 | +SD | FISH |
| 1C | 65 | F | Ovarian | 1 | Liver cyst | 5 | — | FISH |
| 1D | 78 | F | Endometrial | 2 | Peritoneum | 2 | +PR*** | — |
| 1E | 74 | F | Breast | 1 | Breast, bone | 8 | — | IHC3 |
| 1F | 37 | F | Breast | 0 | Lung | 3 | — | IHC3 |
| Cohort 2:2A | 57 | M | Adrenal | 1 | Lung, liver | 2 | +SD | — |
| 2B | 55 | M | Pancreas | 0 | Pancreas | 3 | — | — |
| 2C | 67 | F | Ovarian | 1 | Liver | 9 | — | — |
| 2D | 59 | M | Rectal | 1 | Lung, liver | 3 | — | — |
| 2E | 53 | F | Leiomyosarcoma | 0 | Lung | 4 | — | — |
| 2F | 75 | F | Endometrial | 1 | Lung | 2 | — | FISH |
| Cohort 3:3A | 66 | F | Breast | 1 | Liver | 6 | — | IHC3 |
| 3B | 41 | F | Breast | 0-1 | Liver | 4 | — | IHC3 |
| 3C | 46 | F | Rectal | 2 | Periaortic | 2 | — | — |
| 3D | 58 | M | Colon | 0 | Liver, lung | 3 | — | — |
| 3E | 61 | M | Colorectal | 0 | Liver, bone | 6 | — | — |
| 3F | 66 | F | Breast | 0 | Lung, chest | 3 | — | IHC2 |
| Cohort 4:4A | 65 | F | Ovarian | 0 | Pelvis | 1 | — | IHC2 |
| 4B | 35 | F | GIST | — | Lung | 1 | — | — |
| 4C | 70 | F | Cervical | 1 | Small intestine | 3 | — | — |
| 4D | 74 | F | Ovarian | 0 | Abdomen | 7 | +SD | — |
| 4E | 71 | F | Ovarian | 0 | Abdomen | 3 | +SD | — |
| 4F | 49 | F | NSCLC | 0 | Abdomen | 3 | — | — |
Patients with histologically confirmed metastatic and/or recurrent solid tumors were eligible for enrollment after having received standard therapy and were no longer responding. Patients were not required to have HER-2 over-expression for enrollment.
Abbreviations: ECOG PS, Eastern Cooperative Oncology Group performance status; HER2, human epidermal growth factor receptor 2; +, clinical response; —, no clinical response; SD, stable disease; SCC, squamous cell carcinoma; FISH, fluorescent in situ hybridization; PR, partial response; IHC, imunohistochemistry; GIST, gastrointestinal stromal tumor; NSCLC, non–small-cell lung cancer.