drugset / Trial / NCT03406364
Assess the Safety and Activity of Combined MG005 and Sorafenib (NEXAVAR®) Treatment With Solid Tumor
NaSequentialOpen-labelTreatment
Summary
The proposed initial trial is a Phase I, open label study to evaluate the safety and explore efficacy of MG005 in combination with sorafenib in patients with solid tumor. The eligible patients will receive 200 mg of sorafenib with 3 pre-defined dose levels of GW5074, escalated from 750 mg to 1500 mg (daily dose), to determine the Maximum Tolerated Dose (MTD) and dose limiting toxicities (DLT) (if any) at Phase I stage.
Timeline
- Start
- 2018-06-06
- Primary completion
- 2020-01-09
- Completion
- 2020-07-24
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | MG005 | Unknown | 750 mg | — |
| Subject | MG005 | Unknown | 1500 mg | — |
| Background | Sorafenib | Small molecule | 200 mg | — |