Trastuzumab Biosimilar (Samfenet®) Plus Treatment of Physician's Choice (TPC) in Patients With HER2-positive Solid Tumor

PHASE2UnknownINTERVENTIONAL
Enrollment

42

Participants

Timeline

Start Date

December 30, 2019

Primary Completion Date

December 30, 2019

Study Completion Date

December 30, 2019

Conditions
HER-2 Protein OverexpressionHER-2 Gene Amplification
Interventions
DRUG

Trastuzumab biosimilar

1st cycle 8 mg/kg by IV infusion over 90 mins, from 2nd cycle 6mg/kg by IV infusion over 30 mins. every 3weeks.

DRUG

Gemcitabine Hydrochloride

1000 mg/m2 by IV infusion over 30 minutes on Day 1, Day 8. every 3weeks.

DRUG

Irinotecan Hydrochloride

100 mg/m2 by IV infusion over 90 minutes on Day 1, Day 8. every 3weeks.

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Asan Medical Center

OTHER

lead

Jin-Hee Ahn

OTHER

NCT04215159 - Trastuzumab Biosimilar (Samfenet®) Plus Treatment of Physician's Choice (TPC) in Patients With HER2-positive Solid Tumor | Biotech Hunter | Biotech Hunter