drugset / Trial / NCT03406364

Assess the Safety and Activity of Combined MG005 and Sorafenib (NEXAVAR®) Treatment With Solid Tumor

NCT03406364

Phase 1 Completed 17 enrolled Metagone Biotech Inc.
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

EvaluationDrugModalityDoseRoute
Subject MG005 Unknown 750 mg
Subject MG005 Unknown 1500 mg
Background Sorafenib Small molecule 200 mg

Indications