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
Study ID
NCT07204574
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • CRC

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • HCB101 — DRUG
    QW
  • Bevacizumab — DRUG
    5 mg/kg IV infusion, Day 1, Every 2 weeks
  • Cetuximab (Erbitux) — DRUG
    * 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
  • FOLFIRI (Fluorouracil (5-FU), leucovorin, irinotecan) — DRUG
    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
  • FOLFOX (Oxaliplatin/Leucovorin/5-Fluorouracil) — DRUG
    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

Study Details

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.

Key Dates

Start date
May 14, 2025
Status verified
Sep 2025
Primary completion
Dec 31, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental: HCB101+ Bevacizumab/Cetuximab+ Cetuximab/FOLFOX

Primary Outcome Measure

Number of subjects with MTD of HCB101 in combination with Cetuximab/Bevacizumab, and FOLFOX/FOLFIRI [ Time Frame: 2 Years ]

Central Contacts

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