Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
CTX-009 · 2 trials · 7 indications
Percentage of patients whose Best Overall Response (BOR) is assessed as Complete Response (CR) or Partial Response (PR) as assessed by RECIST 1.1
Percentage of patients whose Best Overall Response (BOR) is assessed as Complete Response (CR) or Partial Response (PR) as assessed by RECIST v1.1
| Arm | Type | Description |
|---|---|---|
| CTX-009 plus Paclitaxel | EXPERIMENTAL | - |
| Paclitaxel | ACTIVE_COMPARATOR | Patients randomized to receive paclitaxel only have the option to crossover to the CTX-009 plus paclitaxel arm after documented disease progression per RECIST v1.1. |
| CTX-009 Treatment | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| CTX-009 | DRUG | IV infusion on day 1 and 14 of every 28 day cycle |
| Paclitaxel | DRUG | IV infusion on day 1, 8, and 15 of every 28 day cycle |
INCLUSION CRITERIA 1. 18 years of age or older 2. Histologically or cytologically confirmed unresectable advanced, metastatic, or recurrent biliary tract cancers (including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, gallbladder cancer, and ampullary carcinoma) 3. Patients mus...