150
Participants
Start Date
March 13, 2025
Primary Completion Date
January 1, 2028
Study Completion Date
January 1, 2029
HCB101
QW
Trastuzumab
8 mg/kg IV loading dose on Day 1 of cycle 1, then 6 mg/kg IV every 21 days;
Pertuzumab
840 mg IV on Day 1, cycled every 21 days;
Oxaliplatin
130 mg/m2 IV on Day 1, cycled every 21 days
Capecitabine
1000 mg/m2 PO BID on Days 1-14, Cycled every 21 days
Ramucirumab
8 mg/kg IV on Days 1 and 15, Cycled every 28 days
Paclitaxel
80 mg/m2 IV on Days 1, 8, and 15, Cycled every 28 days
Bevacizumab
5 mg/kg IV on Day 1, Repeat every 2 weeks; or 7.5 mg/kg IV on Day 1, Repeat every 3 weeks.
Cetuximab
400 mg/m2 first infusion, followed by 250 mg/m2 IV weekly; or 500 mg/m2 IV over 2 hours on Day 1 every 2 weeks;
Irinotecan
180 mg/m2 IV over 30-90 minutes on Day 1 every 2 weeks
Leucovorin
400 mg/m2 IV on Day 1 every 2 weeks
5-FU
400 mg/ m2 IV bolus on Day 1, followed by 1200 mg/m2/day x 2 days (total 2400 mg/m2 over 46-48 hours) IV continuous infusion Repeat every 2 weeks
Toripalimab
240 mg/kg IV on Day 1 Cycled every 21 days
Albumin-bound paclitaxel
125 mg/m2 IV on day 1 and Day 8 Cycled every 21 days
Pembrolizumab
200 mg IV day 1; given every 21 days
Gemcitabine
1000 mg/m2 IV days 1 and 8
RECRUITING
Cancer Hospital of Shandong First Medical University, Jinan
Lead Sponsor
FBD Biologics Limited
INDUSTRY