drugset / Trial / NCT03645980
DKN-01 Inhibition in Advanced Liver Cancer
Non-randomizedSequentialOpen-labelTreatment
Summary
This clinical trial is a prospective, open label, single arm oncological phase I/II trial in patients with hepatocellular carcinoma and WNT signaling alterations. The trial consists of two parts: Part A is a phase I study investigating the safety of DKN-01 administered as mono- as well as combination therapy with sorafenib in a 2 step dose escalation.Part B is a phase II study to investigate the anti-tumor activity and safety of DKN-01 in patients with advanced HCC. DKN-01 is administered at the recommend phase II dose (RP2D) for monotherapy and at the recommend phase II dose for combination therapy established in Part A.
Timeline
- Start
- 2018-10-10
- Primary completion
- 2021-08-31
- Completion
- 2022-08-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | DKN-01 | Monoclonal antibody | 150 mg | Intravenous |
| Subject | DKN-01 | Monoclonal antibody | 300 mg | Intravenous |
| Subject | DKN-01 | Monoclonal antibody | 600 mg | Intravenous |
| Background | Sorafenib | Small molecule | — | — |