The Phase 1b/IIa, Open-label, Dose Escalation and Dose Expansion to Evaluate Safety, Tolerability, and Preliminary Efficacy of the Combination of HCB101, Cetuximab/Bevacizumab, and FOLFOX/FOLFIRI in Advanced or Metastatic Colorectal Cancer

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

May 14, 2025

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2025

Conditions
CRC
Interventions
DRUG

HCB101

QW

DRUG

Bevacizumab

5 mg/kg IV infusion, Day 1, Every 2 weeks

DRUG

Cetuximab (Erbitux)

"* Initial dose: 400 mg/m² IV infusion, over \>2 hours, Day 1~* Maintenance dose: 250 mg/m² IV infusion, over 60 minutes, Day 1, weekly OR 500 mg/m² IV infusion, over \>2 hours, Day 1, every 2 weeks"

DRUG

FOLFIRI (Fluorouracil (5-FU), leucovorin, irinotecan)

Irinotecan: 180 mg/m² IV infusion over 30-90 minutes, Day 1, Every 2 weeks Folinic acid (Leucovorin): 400 mg/m² IV infusion over 2 hours, Day 1, Every 2 weeks 5-Fluorouracil (5-FU): 400 mg/m² IV bolus, Day 1; then 1200 mg/(m²·day) × 2 days continuous IV infusion (total 2400 mg/m² over 46-48 hours, Every 2 weeks

DRUG

FOLFOX (Oxaliplatin/Leucovorin/5-Fluorouracil)

Folinic acid (Leucovorin): 400 mg/m² IV infusion over 2 hours, Day 1, Every 2 weeks 5-Fluorouracil (5-FU): 400 mg/m² IV bolus, Day 1; then 1200 mg/(m²·day) × 2 days continuous IV infusion (total 2400 mg/m² over 46-48 hours), Every 2 weeks Oxaliplatin: 85 mg/m² IV infusion over 2 hours, Day 1, Every 2 weeks

Trial Locations (1)

Unknown

RECRUITING

Linkou Chang-Gung Memorial Hospital, Taoyuan District

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

FBD Biologics Limited

INDUSTRY

lead

Chang Gung Memorial Hospital

OTHER

NCT07204574 - The Phase 1b/IIa, Open-label, Dose Escalation and Dose Expansion to Evaluate Safety, Tolerability, and Preliminary Efficacy of the Combination of HCB101, Cetuximab/Bevacizumab, and FOLFOX/FOLFIRI in Advanced or Metastatic Colorectal Cancer | Biotech Hunter | Biotech Hunter