Safety and Efficacy of HCB101 in Combination With Multiple Agents in Patients With Advanced Solid Tumors

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

150

Participants

Timeline

Start Date

March 13, 2025

Primary Completion Date

January 1, 2028

Study Completion Date

January 1, 2029

Conditions
Solid Cancer
Interventions
DRUG

HCB101

QW

DRUG

Trastuzumab

8 mg/kg IV loading dose on Day 1 of cycle 1, then 6 mg/kg IV every 21 days;

DRUG

Pertuzumab

840 mg IV on Day 1, cycled every 21 days;

DRUG

Oxaliplatin

130 mg/m2 IV on Day 1, cycled every 21 days

DRUG

Capecitabine

1000 mg/m2 PO BID on Days 1-14, Cycled every 21 days

DRUG

Ramucirumab

8 mg/kg IV on Days 1 and 15, Cycled every 28 days

DRUG

Paclitaxel

80 mg/m2 IV on Days 1, 8, and 15, Cycled every 28 days

DRUG

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.

DRUG

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;

DRUG

Irinotecan

180 mg/m2 IV over 30-90 minutes on Day 1 every 2 weeks

DRUG

Leucovorin

400 mg/m2 IV on Day 1 every 2 weeks

DRUG

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

DRUG

Toripalimab

240 mg/kg IV on Day 1 Cycled every 21 days

DRUG

Albumin-bound paclitaxel

125 mg/m2 IV on day 1 and Day 8 Cycled every 21 days

DRUG

Pembrolizumab

200 mg IV day 1; given every 21 days

DRUG

Gemcitabine

1000 mg/m2 IV days 1 and 8

Trial Locations (1)

Unknown

RECRUITING

Cancer Hospital of Shandong First Medical University, Jinan

Sponsors
All Listed Sponsors
lead

FBD Biologics Limited

INDUSTRY

NCT06771622 - Safety and Efficacy of HCB101 in Combination With Multiple Agents in Patients With Advanced Solid Tumors | Biotech Hunter | Biotech Hunter