drugset / Trial / NCT06564623
Targeting Driver Oncogenes With a Peptide Vaccine Plus Durvalumab and Tremelimumab for Patients With Biliary Tract Cancers (BTC)
Phase 1
Recruiting
25 enrolled
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
AstraZeneca · collabPrivate Philanthropic Funds · collab
NaSingle-groupOpen-labelTreatment
Summary
The purpose of this study is to evaluate the safety and the immune response of personalized mutant peptide vaccine with poly-ICLC adjuvant (mBTCvax) in combination with durvalumab and tremelimumab following front-line treatment in patients with advanced stage BTC.
Timeline
- Start
- 2025-05-27
- Primary completion
- 2029-03
- Completion
- 2029-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Durvalumab | Monoclonal antibody | 1500 mg | Intravenous |
| Subject | Hiltonol | Other / unclassified | 0.5 mg | — |
| Subject | Tremelimumab | Monoclonal antibody | 300 mg | Intravenous |
| Subject | mBTCvax | Vaccine | 0.3 mg | — |
| Subject | mBTCvax | Vaccine | 2.4 mg | — |