NCT04194801 - A Phase Ib/II Study of Fisogatinib(BLU-554) in Subjects With Hepatocellular Carcinoma | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

December 16, 2019

Primary Completion Date

October 20, 2021

Study Completion Date

October 20, 2021

Conditions

Hepatocellular Carcinoma

Interventions

DRUG

Phase Ib: Fisogatinib (BLU-554) 400mg in combination with Sugemalimab (CS1001) 1200mg

Phase Ib: participants received 400 mg Fisogatinib (BLU-554) once daily (QD), in combination with 1200mg fixed dose Sugemalimab (CS1001) once every 3 weeks (Q3W). Every 21 days (3 weeks) will be considered as one cycle.

DRUG

Phase Ib: Fisogatinib (BLU-554) 600mg in combination with Sugemalimab (CS1001) 1200mg

Phase Ib: participants received 600 mg Fisogatinib (BLU-554) QD, in combination with 1200mg fixed dose Sugemalimab (CS1001) Q3W. Every 21 days (3 weeks) will be considered as one cycle.

DRUG

Phase II: Fisogatinib (BLU-554) 600mg in combination with Sugemalimab (CS1001) 1200mg

Phase II: participants received 600 mg Fisogatinib (BLU-554) QD, in combination with 1200mg fixed dose Sugemalimab (CS1001) Q3W. Every 21 days (3 weeks) will be considered as one cycle.

Trial Locations (3)

150081

Harbin Medical University Cancer Hospital, Harbin

201203

Shanghai East Hospital, Shanghai

Unknown

Nanfang Hospital,, Guangzhou