drugset / Trial / NCT06591520
AK112 Combined With Chemotherapy Versus Durvalumab Combined With Chemotherapy in Advanced Biliary Tract Cancer
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This is a phase 3 study. All subjects are patients with unresectable locally advanced or metastatic biliary tract cancer (BTC), Eastern Cooperative Oncology Group (ECOG) performance status 0-1. The purpose of this study is to evaluate the efficacy and safety of AK112 in combination with chemotherapy versus durvalumab in combination with chemotherapy in patients with unresectable locally advanced or metastatic BTC.
Timeline
- Start
- 2024-10-20
- Primary completion
- 2026-10
- Completion
- 2027-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Durvalumab | Monoclonal antibody | 1500 mg | Intravenous |
| Subject | Ivonescimab | Monoclonal antibody | — | Intravenous |
| Comparator | Cisplatin | Other / unclassified | 25 mg/m2 | Intravenous |
| Comparator | Gemcitabine | Small molecule | 1000 mg/m2 | Intravenous |