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HNSCCPhase 1/2NCT07136545

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)

A Phase 1/2 study testing HCB101 and Pembrolizumab in people with HNSCC, run by Taipei Veterans General Hospital, Taiwan at 3 sites in Taiwan.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

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 pembrolizumab in patients with platinum-refractory recurrent/metastatic HNSCC. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HNSCC
What is being tested?
HCB101 and Pembrolizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
3 sitesTaiwan
Study dates
13 Aug 2025to 31 Dec 2026
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

  • 1. Subjects 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 in this protocol, including study visits and study-related procedures.
  • 2. Male and female subjects 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.
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  • 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 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 ≥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 subjects who do not receive therapeutic anticoagulation). For subjects receiving therapeutic anticoagulation, the INR should be within the therapeutic range for the intended use of the anticoagulants.)
  • 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).

Who cannot join

  • 1. Medical Conditions:
  • a) With a known history of hypersensitivity to any components of the study intervention.
  • b) Subjects 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 and other malignancies that have been treated with no relapse within 2 years.
  • c) 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 prednisolone or equivalent per day) may participate.
  • 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; 2)History of unstable angina within 6 months prior to the first dose of study intervention; 3)New-onset angina or myocardial infarction within 6 months prior to the first dose of study intervention; 4)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.
  • 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, pacemaker installation, or previous diagnosis of congenital long QT syndrome).
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  • 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 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, Grade 2 chemotherapy-induced neuropathy.)
  • 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, insulin, or physiologic corticosteroids for adrenal or pituitary insufficiency) is allowed.
  • 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) Subjects who have undergone major surgery or radical radiotherapy within 28 days prior to the first dose of study intervention.
  • b) Subjects 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 therapy) within 14 days or 5 half lives, whichever is longer, prior to the first dose of the study intervention.
  • c) Subjects who have used herbal medication within 14 days prior to the first dose of the study intervention.
  • d) Subjects 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 for daily aspirin ≤ 100 mg/QD.
  • e) Subjects who have received any treatment targeting the CD47 or SIRPα pathway.
  • f) Subjects who have previously received pembrolizumab treatment.
  • g) Subjects who have received a live vaccine within 30 days prior to pembrolizumab administration.
  • h) Subjects 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 investigational device was used within 28 days prior to the first dose of study intervention.
  • 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 subjects who have received systemic antibiotics within 7 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).
  • b) Known history of human immunodeficiency virus (HIV) infection.
  • c) Active tuberculosis.
  • d) Known history of hepatitis B or hepatitis C infection. Subjects 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 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

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Iris chang contact

+886-2-2871-2121 ext. 65718

iris.c8987223@protonmail.com

Taiwan3 sites, 3 recruiting

  • National Taiwan University Hospital

    Taipei, Taipei City, 100

    Ching-Yi Chan, +886-2-23123456 #267439, winifred0115@gmail.com

    Huai-Cheng Huang

    Recruiting

  • Taipei Veterans General Hospital

    Taipei, Taipei City, 112

    Mu-Hsin Chang, +886-2-2871-2121 ext. 65718, ptchang@vghtpe.gov.tw

    Iris Chang, +886-2-2871-2121 ext. 65718, iris.c8987223@protonmail.com

    Recruiting

  • Chang-Gung Memorial Hospital(Lin-Kou)

    Taoyuan, Guishan District, 333

    Rina Chung, +886-3-328-1200 ext.8425, rinachung.tw@yahoo.com.tw

    Chia-Hsun Hsieh

    Recruiting

Other trials in Taiwan

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 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).

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 pembrolizumab (200 mg IV day 1; given every 21 days) 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
HNSCC
Being tested
HCB101, Pembrolizumab
Medical subject headings
Squamous Cell Carcinoma of Head and Neck

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HCB101Drug

    QW

  • PembrolizumabDrug

    200 mg IV on Day 1, cycled every 21 days;

Study groups in NCT07136545
Study groupRoleWhat they receive
HCB101+PembrolizumabExperimentalNot described
Receives: Drug: HCB101; Drug: Pembrolizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of subjects with MTD of HCB101 in combination with pembrolizumab

    To evaluate the safety and efficacy of HCB101 in combination with pembrolizumab

    Measured: 2 Years

  2. Overall Rate Response (ORR)

    To evaluate the safety and efficacy of HCB101 in combination with pembrolizumab

    Measured: 2 Years

Secondary outcomes (3)

  1. Number/incidence and percentage of subjects with AEs, SAEs, and TEAEs

    To characterize the safety profiles of HCB101 in combination with pembrolizumab.

    Measured: 2 Years

  2. Progression-Free Survival (PFS)

    To evaluate the anti-tumor activity of HCB101 in combination with pembrolizumab.

    Measured: 2 Years

  3. Quality of life (EORTC QLQ-H&N35) change

    To evaluate the quality of life (QOL) change after treatment of HCB101 in combination with pembrolizumab

    Measured: 2 Years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Aug 2025
  2. Study start13 Aug 2025
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

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
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07136545
Sponsor's protocol ID
2025-01-015B
Status last verified
Jul 2026
First submitted
5 Aug 2025
Last updated
6 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing HCB101 and Pembrolizumab in people with HNSCC, run by Taipei Veterans General Hospital, Taiwan at 3 sites 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 16 inclusion and 31 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 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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 Iris chang (+886-2-2871-2121 ext. 65718, iris.c8987223@protonmail.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 pembrolizumab (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?

On the ClinicalTrials.gov record for NCT07136545.

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 6 Jul 2026.

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