Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05506943 | A Study of CTX-009 in Combination With Paclitaxel in Adult Patients With Unresectable Advanced, Metastatic or Recurrent Biliary Tract Cancers (COMPANION-002) | PHASE2 | ACTIVE NOT_RECRUITING | 168 | — | — | Jan 9, 2023 | Dec 1, 2026 | May 7, 2026 | 34 | United States |
Percentage of patients whose Best Overall Response (BOR) is assessed as Complete Response (CR) or Partial Response (PR) as assessed by RECIST 1.1
| 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. |
| 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...