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Tests treatment safety and results for CRC
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
What this study is testing
What is HCB101?
HCB101 is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for crc.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- people are able to understand and willing to provide signed informed consent as described in Appendix 1, Section 10.1.3, which includes compliance...
- Male and female people 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...
- 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.
You likely can't join if
- people 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...
- Primary tumor in the central nervous system (CNS), or active or untreated CNS metastases and/or carcinomatous meningitis. people with previously...
- Clinically significant cardiovascular condition, including:
- History of congestive heart failure (New York Heart Association Class \>2);
See the full eligibility criteria
- people 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...
- Male and female people 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...
- 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.
- 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...
- 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 people who do not receive therapeutic anticoagulation).
- A) Female people 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...
- people 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...
- Primary tumor in the central nervous system (CNS), or active or untreated CNS metastases and/or carcinomatous meningitis. people with previously treated brain metastases may participate, provided they are clinically...
- Clinically significant cardiovascular condition, including:
- 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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Taoyuan, Taiwan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Taoyuan, Taiwan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.