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New treatment option for HNSCC
Official title A Phase I/II Trial of HCB101 in Combination With Pembrolizumab for Patients With Platinum-Refractory, Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (SirH&N Trial)
ClinicalTrials.gov ID: NCT07136545
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 hnscc.
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 pembrolizumab in patients with platinum-refractory recurrent/metastatic HNSCC. 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
- 1\. people are able to understand and willing to provide signed informed consent as described in protocol, which includes compliance with the...
- 2\. Male and female people of ≥18 years of age, inclusive, at the time of signing the informed consent.
- 3\. With histologically/cytologically confirmed diagnosis of HNSCC
- 4\. With progression after 1st cisplatin based therapy for R/M HNSCC or within 6 months after cisplatin based CCRT
- 5\. Must have at least 1 measurable lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
You likely can't join if
- 1\. Medical Conditions:
- a) With a known history of hypersensitivity to any components of the study intervention.
- b) people who have other malignancies requiring treatment within 2 years prior to the first dose of study intervention will be excluded, except for...
- c) Primary tumor in the central nervous system (CNS), or active or untreated CNS metastases and/or carcinomatous meningitis. people with previously...
- d) Clinically significant cardiovascular condition, including 1)History of congestive heart failure (New York Heart Association Class \>2), with only...
- e) History or presence of an abnormal ECG that, in the Investigator's opinion, is clinically meaningful (including QT interval corrected for heart...
See the full eligibility criteria
Who can join
- 1\. people are able to understand and willing to provide signed informed consent as described in protocol, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and...
- 2\. Male and female people of ≥18 years of age, inclusive, at the time of signing the informed consent.
- 3\. With histologically/cytologically confirmed diagnosis of HNSCC
- 4\. With progression after 1st cisplatin based therapy for R/M HNSCC or within 6 months after cisplatin based CCRT
- 5\. Must have at least 1 measurable lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
- 6\. Must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 at Screening.
- 7\. Have a life expectancy of ≥12 weeks (according to the Investigator's judgment).
- 8\. 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...
- 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 ≥50 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)...
- 9\. 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).
What rules you out
- 1\. Medical Conditions:
- a) With a known history of hypersensitivity to any components of the study intervention.
- b) people who have other malignancies requiring treatment within 2 years prior to the first dose of study intervention will be excluded, except for radically treated locally curable basal or squamous cell skin cancer...
- c) 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...
- d) Clinically significant cardiovascular condition, including 1)History of congestive heart failure (New York Heart Association Class \>2), with only heart failure with preserved ejection fraction (HFpEF) included...
- e) 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...
- f) 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...
- g) With known inherited or acquired bleeding disorders or bleeding diathesis.
- h) With a previously documented diagnosis of hemolytic anemia or Evans Syndrome in the last 3 months.
- i) With active autoimmune diseases that required systemic treatment (e.g., disease-modifying agents, corticosteroids, or immunosuppressants) within the past two years are excluded. Replacement therapy (e.g., thyroxine...
- j) With a history of or current non-infectious pneumonitis.
- k) With a history of severe hypersensitivity to monoclonal antibodies.
- 2\. Prior/Concomitant Therapy/Treatment
- a) people who have undergone major surgery or radical radiotherapy within 28 days prior to the first dose of study intervention.
- b) people who have undergone any investigational or approved systemic cancer therapy (including chemotherapy, immunotherapy, hormonal therapy, and herbal/alternative therapies with anti-cancer indications or targeted...
- c) people who have used herbal medication within 14 days prior to the first dose of the study intervention.
- d) people who are active using 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...
- e) people who have received any treatment targeting the CD47 or SIRPα pathway.
- f) people who have previously received pembrolizumab treatment.
- g) people who have received a live vaccine within 30 days prior to pembrolizumab administration.
- h) people diagnosed with immunodeficiency, receiving systemic steroid therapy, or having received any other form of immunosuppressive therapy within 7 days prior to the first dose of pembrolizumab.
- 3\. 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. An...
- 4\. Reproductive and breastfeeding
- a) Women of reproductive potential who are unable to use effective contraception during treatment and for 4 months after the last dose.
- b) Women who are breastfeeding during treatment and for 4 months after the last dose.
- 5\. Infections:
- a) An uncontrolled acute infection, an active infection requiring systemic treatment, or people who have received systemic antibiotics within 7 days prior to the first dose of the study intervention (Note: prophylaxis...
- b) Known history of human immunodeficiency virus (HIV) infection.
- c) Active tuberculosis.
- d) Known history of hepatitis B or hepatitis C infection. people who test positive for hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) antibody.
- 6\. 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...
The study team makes the final eligibility decision.
Where it's taking place
- Taoyuan, Guishan District, Taiwan
- Taipei, Taipei City, 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, Guishan District, Taiwan; Taipei, Taipei City, 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.