Actively Recruiting
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
Led by Chang Gung Memorial Hospital · Updated on 2025-10-02
40
Participants Needed
1
Research Sites
33 weeks
Total Duration
On this page
Sponsors
C
Chang Gung Memorial Hospital
Lead Sponsor
F
FBD Biologics Limited
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand and willing to provide signed informed consent
- Male or female 18 years of age or older at consent
- Histologically or cytologically confirmed unresectable locally advanced or metastatic colorectal cancer with RAS and BRAF wild-type
- Experienced treatment failure with prior chemotherapy for advanced or metastatic disease
- At least one measurable lesion per RECIST v1.1
- ECOG performance status of 0 to 2 at screening
- Able to provide archived or fresh tumor tissue samples for CD47 expression, immune score, and whole-exome sequencing
- Life expectancy of at least 12 weeks
- Adequate organ function based on specified laboratory values
- Female participants must either have no childbearing potential, be postmenopausal, or have a negative pregnancy test and agree to use effective contraception
- Male participants must have undergone vasectomy or agree to use effective contraception and avoid sperm donation during and for 6 months after treatment
You will not qualify if you...
- Known hypersensitivity to any study treatment components
- Other cancers requiring treatment within 2 years except certain skin cancers and other cancers without recurrence
- Primary CNS tumor, active or untreated CNS metastases, or carcinomatous meningitis (unless stable brain metastases for at least 28 days and no high-dose steroids within 14 days)
- Significant cardiovascular conditions including recent unstable angina, myocardial infarction, or uncontrolled arrhythmias
- Abnormal ECG considered clinically meaningful by investigator
- Unresolved treatment-related toxicities above Grade 1 except alopecia and anemia
- Known bleeding disorders or bleeding tendency
- Dependence on red blood cell transfusions exceeding 2 units in 4 weeks prior to screening
- Recent major surgery or radical radiotherapy within 28 days prior to first dose
- Recent palliative radiotherapy within 14 days prior to first dose
- Use of radioactive drugs within 56 days prior to first dose
- Use of systemic cancer therapy within 14 days or 5 half-lives prior to first dose
- Use of herbal medication within 14 days prior to first dose
- Active use of vitamin K antagonist anticoagulants like warfarin
- Prior treatment targeting CD47 or SIRPα pathway
- Receipt or planned receipt of live virus or bacterial vaccines within 28 days prior to first dose
- Participation in another clinical study with investigational product within 14 days or 5 half-lives prior to first dose
- Uncontrolled acute infection or active infection requiring systemic treatment within 14 days prior to first dose
- Known HIV infection with CD4+ T-cell count below 350 cells/μL or refusal to test
- Active hepatitis B or C infection requiring treatment
- Active tuberculosis
- History of alcoholism or drug abuse
- Any medical, psychiatric, or social condition interfering with study participation or safety
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Linkou Chang-Gung Memorial Hospital
Taoyuan, Taiwan
Actively Recruiting
Research Team
H
Hung-Chih Hsu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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