Table 4.
Dosing, mutation status and virology
| Seq # | Dose Level | Diagnosis | # Rx | BR | Mutation Status
|
NA | Viral shedding
|
||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Ras (codon)
|
Braf (codon) | Serum | Saliva | Urine | Feces | ||||||||
| 12 | 13 | 61 | 600 | ||||||||||
| 101 | 1 | Ovarian | 1 | SD | WT | WT | WT | WT | D8 | N | N | N | N |
| 102 | 1 | Colon | 1 | PD | WT | WT | WT | WT | D8 | N | N | N | N |
| 103 | 1 | Leio* | 1 | SD | WT | WT | WT | WT | D8 | N | N | N | N |
| 201 | 2 | Colon | 1 | PD | G>V | WT | WT | WT | D8 | N | N | N | N |
| 202 | 2 | Ovarian | 3 | SD | WT | WT | WT | WT | D8 | N | N | N | N |
| 203 | 2 | Carcinoid | 1 | SD | ND | ND | ND | ND | D8 | D1 | D3 | D3 | N |
| 301 | 3 | Cervical | 1 | PD | WT | WT | WT | WT | D5 | N | N | N | N |
| 302 | 3 | Ovarian | 1 | SD | WT | WT | WT | WT | D5 | D3 | N | D3 | N |
| 303 | 3 | Prostate | 1 | PD | G>A | WT | WT | WT | D28 | N | N | N | N |
| 401 | 4 | Ovarian | 1 | PD | WT | WT | WT | WT | D5 | N | N | N | N |
| 402 | 4 | Colon | 1 | PD | WT | WT | WT | WT | D5 | N | N | N | N |
| 403 | 4 | Cervical | 1 | PD | WT | WT | WT | WT | D8 | N | N | N | N |
| 501 | 5 | Breast | 7 | PR | G>A | WT | WT | WT | D14 | N | D149 | N | D64 |
| 502 | 5 | Breast | 1 | PD | G>A | WT | WT | V>E | D8 | N | N | N | N |
| 503 | 5 | Lung | 1 | PD | WT | WT | WT | WT | D8 | D21 | N | D8 | N |
| 601 | 6 | Colon | 1 | PD | WT | WT | WT | WT | D8 | N | N | D14 | N |
| 602 | 6 | Ovarian | 1 | SD | WT | WT | WT | WT | D8 | N | N | N | N |
| 603 | 6 | Ovarian | 2 | SD | G>V | WT | WT | WT | D1 | D1 | D1 | D1 | D8 |
Abbreviations: Leio* leiomyosarcoma, # Rx number of doses, BR best response, SD stable disease, PD progressive disease, PR partial response, NA neutralizing antibody, N not detected, D earliest day of detection, ND not done, WT wild type, G>V glycine>valine (mutation), G>A glycine >alanine (mutation), V>E valine>glutamic acid (mutation)