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

PHASE1CompletedINTERVENTIONAL
Enrollment

17

Participants

Timeline

Start Date

June 6, 2018

Primary Completion Date

January 9, 2020

Study Completion Date

July 24, 2020

Conditions
Solid Tumor
Interventions
DRUG

MG005

"Phase I:~Eligible patients will receive different dosages of GW5074 in 1 of the 3 dose cohorts plus 200 mg of sorafenib. Dose cohorts will be escalated sequentially from Cohort 1 at 750 mg QD GW5074 plus 200 mg QD sorafenib to Cohort 2 at 1500 mg QD GW5074 plus 200 mg QD sorafenib, and Cohort 3 at 750 mg BID GW5074 plus 200 mg QD sorafenib. Owing to the fact that there is no previous human experience for GW5074, Cohort 1 will include a monotherapy stage with 750 mg QD GW5074 prior to administration of the GW5074 and sorafenib combination to initially assess the safety of GW5074 monotherapy."

Trial Locations (1)

114

Tri-Service General Hospital, Taipei

Sponsors
All Listed Sponsors
lead

Metagone Biotech Inc.

INDUSTRY

NCT03406364 - Assess the Safety and Activity of Combined MG005 and Sorafenib (NEXAVAR®) Treatment With Solid Tumor | Biotech Hunter | Biotech Hunter