CRCPhase 1/2NCT07204574
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
A Phase 1/2 study testing HCB101, Bevacizumab and Cetuximab (Erbitux) in people with CRC, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CRC
- What is being tested?
- HCB101, Bevacizumab and Cetuximab (Erbitux)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- 14 May 2025to 31 Dec 2025
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects are able to understand and willing to provide signed informed consent as described in Appendix 1, Section 10.1.3, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol, including study visits and study-related procedures.
- Male and female subjects of ≥18 years of age, inclusive, at the time of signing the informed consent.
- With histologically/cytologically confirmed diagnosis of unresectable locally advanced or metastatic colorectal cancer, with both RAS and BRAF wild-type, who have experienced treatment failure with prior chemotherapy for locally advanced or metastatic disease (intended for second-line treatment). Previous chemotherapy may have included 5-FU, oxaliplatin, or irinotecan.
- Must have at least 1 measurable lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
- Must have Eastern Cooperative Oncology Group (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 (WES) analysis, if applicable.
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- Have a life expectancy of ≥12 weeks (according to the Investigator's judgment).
- Have adequate organ function, as indicated by the following laboratory parameters in below (had not received a blood transfusion, apheresis infusion, erythropoietin, granulocyte colony-stimulating factor, and other relevant medical support within 14 days prior to the administration of the first dose of study intervention).
- -- a) Absolute neutrophil count ≥1.5 × 109/L
- -- b) Platelets ≥75 × 109/L
- -- c) Hemoglobin ≥9.5 g/dL
- d) Total bilirubin ≤1.5 × upper limit of normal (ULN), <3.0 × ULN if known Gilbert's disease
- e) Alanine aminotransferase and aspartate aminotransferase ≤3× ULN and ≤5× ULN for subject with liver metastasis
- f) Creatinine clearance ≥30 mL/min (using Cockcroft Gault equation)
- g) Coagulation: International normalized ratio (INR), prothrombin time (PT), and activated partial thromboplastin time (aPTT) ≤1.5× ULN (The INR applies only to subjects who do not receive therapeutic anticoagulation).
- A) Female subjects should meet at least 1 of the following criteria before they can participate in the study:
- Females who have no childbearing potential (i.e., physiologically incapable of pregnancy), including those who have undergone hysterectomy, bilateral oophorectomy, or bilateral salpingectomy.
- Postmenopausal (total cessation of menses for ≥ 1 year).
- Women of childbearing potential (WOCBP) must have a negative serum pregnancy test during the Screening Period (within 7 days prior to the first dose of the study intervention), must not be lactating, and must be willing to practice a highly effective contraceptive method throughout the study (i.e., from study entry up to 6 months after the last dose of the study intervention). A highly effective method of contraception is defined as one that results in a low failure rate, i.e., less than 1% per year when used consistently and correctly. For the definition of WOCBP and highly effective methods of contraception.
- Male subjects are eligible to participate in the study if they have undergone a vasectomy or agree to use a highly effective method of contraception and refrain from donating sperm from study entry up to 6 months after the last dose of the study intervention.
Who cannot join
- Subjects are excluded from the study if any of the following criteria apply:
- -Medical Conditions
- With a known history of hypersensitivity to any components of the study intervention.
- With other malignancies requiring treatment within 2 years prior to the first dose will be excluded, except for locally curable basal cell or squamous cell skin cancer treated with curative intent, and other malignancies with no recurrence within 2 years.
- Primary tumor in the central nervous system (CNS), or active or untreated CNS metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate, provided they are clinically stable for at least 28 days and have no evidence of new or enlarging brain metastases and no requirements for high-dose corticosteroids 14 days prior to dosing with study intervention. Subjects on low-dose corticosteroids (<20 mg prednisone or equivalent per day) may participate.
- Clinically significant cardiovascular condition, including:
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- History of congestive heart failure (New York Heart Association Class >2);
- History of unstable angina within 6 months prior to the first dose of study intervention;
- New-onset angina or myocardial infarction within 6 months prior to the first dose of study intervention;
- New-onset of atrial fibrillation, supraventricular arrhythmia, or ventricular arrhythmia within 6 months prior to the first dose of study intervention and still in unstable condition and requiring treatment or intervention. History of atrial fibrillation, supraventricular arrhythmia, or ventricular arrhythmia will be allowed, provided the condition is stably controlled.
- History or presence of an abnormal ECG that, in the Investigator's opinion, is clinically meaningful (including QT interval corrected for heart rate using Fridericia's correction [QTcF] >470 msec at Screening, pacemaker installation, or previous diagnosis of congenital long QT syndrome).
- Any previous treatment-related toxicities which have not recovered to ≤ Grade 1 as evaluated by National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0 or baseline, except alopecia and anemia (Note: subjects with chronic Grade 2 toxicities which are well managed and stable may be eligible per the discretion of the Investigator after discussion with the Sponsor and medical monitor, e.g., Grade 2 chemotherapy-induced neuropathy.)
- 6. With known inherited or acquired bleeding disorders or bleeding diathesis. 7. Known congenital or acquired bleeding disorders or bleeding tendency. 8. Have RBC transfusion dependence defined as requiring more than 2 units of RBC transfusions during the 4-week period prior to Screening.
- 9. With a previously documented diagnosis of hemolytic anemia or Evans Syndrome in the last 3 months.
- Prior/Concomitant Therapy/Treatment 10. Subjects who have undergone major surgery, or have undergone radical radiotherapy within 28 days prior to the first dose of study intervention.
- 11. Subjects who have undergone palliative radiotherapy within 14 days prior to the first dose of study intervention,=.
- 12. Subjects who have used a radioactive drug (Strontium, Samarium, etc.) within 56 days prior to the first dose of the study intervention.
- 13. Any investigational or approved systemic cancer therapy (including chemotherapy, immunotherapy, hormonal therapy, and herbal/alternative therapies with anti-cancer indications or targeted therapy) administered within 14 days or 5 half lives, whichever is longer, prior to the first dose of the study intervention.
- 14. Have used herbal medication within 14 days prior to the first dose of the study intervention.
- 15. Active use of vitamin K antagonist anticoagulant like warfarin. Use of low molecular weight heparin and factor Xa inhibitors will be permitted on a case-by-case basis. There will be no restriction for daily aspirin ≤ 100 mg/QD.
- 16. Have received any treatment targeting the CD47 or SIRPα pathway. 17. Received or planning to receive live virus or bacterial vaccine within 28 days prior to the first dose of study intervention while the subject receives the study intervention. Subjects who require Corona Virus Disease 2019 (COVID-19) vaccination while on study intervention must receive a non-live vaccine (e.g., one based on messenger RNA [mRNA] or fully inactivated/genetically modified viruses incapable of replication).
- Prior/Concurrent Clinical Study Experience 18. Participation in another clinical study with an investigational product administered in the last 14 days or 5 half-lives (whichever is longer) prior to receiving the first dose of study intervention. Or An investigational device was used within 28 days prior to the first dose of study intervention.
- Infections 19. An uncontrolled acute infection, an active infection requiring systemic treatment, or subjects who have received systemic antibiotics within 14 days prior to the first dose of the study intervention (Note: prophylaxis use of systemic antibiotics treatment for upper tract infection is allowed as long as there is no violation of the requirement of concomitant medications).
- 20. Known history of human immunodeficiency virus (HIV) infection and/or acquired immunodeficiency syndrome or positive HIV testing having CD4+ T-cell counts <350 cells/µL or subjects with unknown HIV infection status who are unwilling to undergo HIV testing.
- 21. Known active hepatitis B or C. Subjects with hepatitis B virus surface antigen (HBsAg) or hepatitis C virus (HCV) antibody positive test results during Screening must be further tested for hepatitis B virus (HBV) deoxyribonucleic acid (DNA) titer (excluding subjects with a DNA titer of more than 2500 copies [cps]/mL or 500 IU/mL) and HCV ribonucleic acid (RNA) (excluding subjects with an HCV RNA concentration exceeding the lower detection limit of the assay) to exclude active hepatitis B or hepatitis C infection requiring treatment. Hepatitis B virus carriers, i.e., subjects with stable hepatitis B infection after drug treatment (DNA titer not exceeding 2500 cps/mL or 500 IU/mL) and hepatitis C infected subjects who received treatment and achieved sustained virologic response for at least 12 weeks can be enrolled. Note: If the lower detection limit of the HBV DNA assay is higher than 2500 cps/mL or 500 IU/mL, the subjects with an HBV DNA assay result lower than the lower detection limit of the assay can be enrolled.
- 22. Active tuberculosis. 23. Known to have a history of alcoholism or drug abuse. 24. Any other medical (e.g., Child-Pugh class B or C, pulmonary, metabolic, congenital, endocrinal or CNS disease, etc.), psychiatric, or social condition deemed by the Investigator to be likely to interfere with a subject's rights, safety, welfare or ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Linkou Chang-Gung Memorial Hospital
Taoyuan
Hung-Chih Hsu, +886-975-368-118, dannyhsuyoyo@gmail.com
Yi-Ting Yang, +886-989-336-747, kikikoko1110@gmail.com
About this study
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
- Being tested
- HCB101, Bevacizumab, Cetuximab (Erbitux), FOLFIRI (Fluorouracil (5-FU), leucovorin, irinotecan), FOLFOX (Oxaliplatin/Leucovorin/5-Fluorouracil)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HCB101Drug
QW
BevacizumabDrug
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 group | Role | What they receive |
|---|---|---|
| Experimental: HCB101+ Bevacizumab/Cetuximab+ Cetuximab/FOLFOX | Experimental | Not described Receives: Drug: HCB101; Drug: Bevacizumab; Drug: Cetuximab (Erbitux); Drug: FOLFIRI (Fluorouracil (5-FU), leucovorin, irinotecan); Drug: FOLFOX (Oxaliplatin/Leucovorin/5-Fluorouracil) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with MTD of HCB101 in combination with Cetuximab/Bevacizumab, and FOLFOX/FOLFIRI
To evaluate the safety and efficacy of HCB101 in combination with Cetuximab/Bevacizumab, and FOLFOX/FOLFIRI
Measured: 2 Years
Overall Rate Response (ORR)
To evaluate the safety and efficacy of HCB101 in combination with Cetuximab/Bevacizumab, and FOLFOX/FOLFIRI
Measured: 2 Years
Secondary outcomes (2)
Number/incidence and percentage of subjects with AEs, SAEs, and TEAEs
To characterize the safety profiles of HCB101 in combination with Cetuximab/Bevacizumab, and FOLFOX/FOLFIRI
Measured: 2 Years
Progression-Free Survival (PFS)
To evaluate the anti-tumor activity of HCB101 in combination with Cetuximab/Bevacizumab, and FOLFOX/FOLFIRI
Measured: 2 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2025
- Study start14 May 2025
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CRCStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- FBD Biologics Limited
- Responsible party
- Principal investigator, Hung-Chih Hsu, Chang Gung Memorial Hospital
- Investigators
- Hung-Chih Hsu, Principal investigator, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07204574
- Sponsor's protocol ID
- 202401753A0
- Status last verified
- Sep 2025
- First submitted
- 24 Sep 2025
- Last updated
- 2 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07204574
- Acronym / sponsor ID
- 202401753A0
- Conditions
- CRC
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Collaborators
- FBD Biologics Limited
- Study start
- 14 May 2025 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 2 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental: HCB101+ Bevacizumab/Cetuximab+ Cetuximab/FOLFOX | Experimental | Drug: HCB101, Drug: Bevacizumab, Drug: Cetuximab (Erbitux), Drug: FOLFIRI (Fluorouracil (5-FU), leucovorin, irinotecan), Drug: FOLFOX (Oxaliplatin/Leucovorin/5-Fluorouracil) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Subjects are able to understand and willing to provide signed informed consent as described in Appendix 1, Section 10.1.3, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol, including study visits and study-related procedures.
- Male and female subjects of ≥18 years of age, inclusive, at the time of signing the informed consent.
- With histologically/cytologically confirmed diagnosis of unresectable locally advanced or metastatic colorectal cancer, with both RAS and BRAF wild-type, who have experienced treatment failure with prior chemotherapy for locally advanced or metastatic disease (intended for second-line treatment). Previous chemotherapy may have included 5-FU, oxaliplatin, or irinotecan.
- Must have at least 1 measurable lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
- Must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 at Screening.
Key exclusion criteria (26 listed)
- -Medical Conditions
- With a known history of hypersensitivity to any components of the study intervention.
- With other malignancies requiring treatment within 2 years prior to the first dose will be excluded, except for locally curable basal cell or squamous cell skin cancer treated with curative intent, and other malignancies with no recurrence within 2 years.
- Primary tumor in the central nervous system (CNS), or active or untreated CNS metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate, provided they are clinically stable for at least 28 days and have no evidence of new or enlarging brain metastases and no requirements for high-dose corticosteroids 14 days prior to dosing with study intervention. Subjects on low-dose corticosteroids (<20 mg prednisone or equivalent per day) may participate.
- Clinically significant cardiovascular condition, including:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HCB101QW | Drug | Experimental: HCB101+ Bevacizumab/Cetuximab+ Cetuximab/FOLFOX |
| Bevacizumab5 mg/kg IV infusion, Day 1, Every 2 weeks | Drug | Experimental: HCB101+ Bevacizumab/Cetuximab+ Cetuximab/FOLFOX |
| 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 | Experimental: HCB101+ Bevacizumab/Cetuximab+ Cetuximab/FOLFOX |
| 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 | Experimental: HCB101+ Bevacizumab/Cetuximab+ Cetuximab/FOLFOX |
| 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 | Drug | Experimental: HCB101+ Bevacizumab/Cetuximab+ Cetuximab/FOLFOX |
Primary outcome
Number of subjects with MTD of HCB101 in combination with Cetuximab/Bevacizumab, and FOLFOX/FOLFIRI
Time frame: 2 Years
To evaluate the safety and efficacy of HCB101 in combination with Cetuximab/Bevacizumab, and FOLFOX/FOLFIRI
Overall Rate Response (ORR)
Time frame: 2 Years
To evaluate the safety and efficacy of HCB101 in combination with Cetuximab/Bevacizumab, and FOLFOX/FOLFIRI
2 secondary outcomes
Number/incidence and percentage of subjects with AEs, SAEs, and TEAEs
Time frame: 2 Years
Progression-Free Survival (PFS)
Time frame: 2 Years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hung-Chih Hsu principal investigator
Chang Gung Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing HCB101, Bevacizumab and Cetuximab (Erbitux) in people with CRC, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hung-Chih Hsu (+886-975-368-118, dannyhsuyoyo@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of subjects with MTD of HCB101 in combination with Cetuximab/Bevacizumab, and FOLFOX/FOLFIRI (time frame: 2 Years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2025.