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

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Chang Gung Memorial Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a non-randomized, open-label, dose-escalation and dose-expansion phase I/II clinical study to evaluate the safety, tolerability, and efficacy of HCB101 in combination with Cetuximab/Bevacizumab, and FOLFOX/FOLFIRI in Advanced or Metastatic Colorectal Cancer. The trial consists of two phases: the dose-escalation phase (I) and the dose-expansion phase (II). Subjects will receive a weekly single dose of HCB101 IV infusion over 60 (±10) minutes on Days 1, 8, and 15 in each 21-day cycle in combination with Bevacizumab (5 mg/kg IV day 1; given every 14 days) /Cetuximab (500 mg/m2 IV day 1; given every 14 days) , and FOLFIRI/FOLFOX until unacceptable AE(s), radiographic or clinically documented disease progression, withdrawal of consent, loss to follow-up, death, or termination of the study whichever occurs first.

Conditions

• CRC

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-05-14
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2025-10-02
• Last updated: 2025-10-02

Locations

1 site across 1 country: Taiwan