RecruitingPhase 1Phase 2NCT07204574

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

Sponsor

Chang Gung Memorial Hospital

Enrollment

40 participants

Start Date

May 14, 2025

Study Type

INTERVENTIONAL

Conditions

CRC

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called HCB101 combined with standard chemotherapy and targeted therapy (cetuximab or bevacizumab with FOLFOX or FOLFIRI) as a second-line treatment for people with advanced or metastatic colorectal cancer that has a specific genetic profile (RAS and BRAF wild-type). HCB101 is designed to help the immune system overcome cancer defenses. **You may be eligible if...** - You are 18 or older with confirmed advanced or metastatic colorectal cancer - Your cancer has been tested and confirmed to be RAS wild-type and BRAF wild-type - Your cancer has progressed after one prior chemotherapy regimen - You have at least one measurable tumor - Your overall health and ability to function is rated as good (ECOG 0–2) - Your organs are functioning adequately - Your expected survival is at least 12 weeks **You may NOT be eligible if...** - Your cancer has RAS or BRAF mutations - You have not had any prior chemotherapy for metastatic disease - You have already received more than one prior treatment line for metastatic disease - You have significant heart, liver, or immune problems - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGHCB101

DRUGBevacizumab

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

DRUGCetuximab (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

DRUGFOLFIRI (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

DRUGFOLFOX (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