drugset / Trial / NCT02560779
Trial of TRC105 and Sorafenib in Patients With HCC
NaSingle-groupOpen-labelTreatment
Summary
The purpose of the phase 1b portion is to evaluate safety and tolerability and determine a recommended phase 2 dose for TRC105 when added to standard dose sorafenib in patients with hepatocellular carcinoma. Up to 18 patients will be treated. The purpose of the phase 2 portion is to estimate the ORR of patients with hepatocellular carcinoma by RECIST 1.1. Up to 21 patients will be treated in phase 2.
Timeline
- Start
- 2016-11
- Primary completion
- 2019-08
- Completion
- 2019-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Carotuximab | Monoclonal antibody | 10 mg/kg | Intravenous |
| Subject | Carotuximab | Monoclonal antibody | 15 mg/kg | Intravenous |
| Background | Sorafenib | Small molecule | 400 mg | Oral |