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Head and Neck Squamous Cell CarcinomaPhase 2NCT05044897

A Clinical Study to Evaluate the Efficacy and Safety of SI-B001 in the Treatment of Recurrent and Metastatic HNSCC

A Phase 2 study testing SI-B001 in people with Head and Neck Squamous Cell Carcinoma, run by Sichuan Baili Pharmaceutical Co., Ltd. at 3 sites in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This multi-center, open label phase II clinical study is performed in patients with recurrent metastatic squamous cell carcinoma of the head and neck progressed on prior anti-PD-1 mab ± platinum-based chemotherapy. This study is investigating the safety and efficacy of SI-B001 as a single agent in patients. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Head and Neck Squamous Cell Carcinoma
What is being tested?
SI-B001
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
11 participants
Where
3 sitesChina
Study dates
20 Oct 2021to Dec 2025
Phase
Phase 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

  • Sign the informed consent voluntarily and comply with the requirements of the program;
  • Age ≥18; Gender is not limited;
  • Expected survival time ≥3 months;
  • Locally advanced squamous cell carcinoma of the head and neck confirmed by histology or pathology as recurrent metastatic or without indications of radical local treatment;
  • Patients who failed or were intolerant to previous anti-PD-1 mab and platinum-containing chemotherapy
  • Treatment failure of PD-1 refers to disease progression during or after PD-1 treatment.
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  • Failure of platinum-containing chemotherapy refers to:
  • disease progression during or after platinum-containing chemotherapy;
  • recurrence or disease progression within 6 months of platinum-containing multi-mode therapy;
  • Agree to provide tumor tissue samples (FFPE block or 10 unstained sections of 5μm size) or fresh tissue samples archiving within one year from primary or metastatic foci. If the patient fails to provide the samples, they can be included after the investigator's judgment;
  • There must be at least one measurable lesion in accordance with the RECIST v1.1 definition. Tumor lesions located in the area of previous radiotherapy or other local regional treatment sites are generally not measurable unless there is definite progression of the lesion or the lesion persists three months after radiotherapy;
  • Physical fitness ECOG score 0 or 1;
  • Adverse reactions to previous antitumor therapy were restored to CTCAE 5.0 ≤1 (except for toxicity judged by the researchers to be of no safety risk, such as hair loss, grade 2 peripheral neurotoxicity, and stable hypothyroidism after hormone replacement therapy);
  • Organ function levels must meet the following requirements and meet the following standards:
  • Bone marrow function: absolute neutrophil count (ANC) ≥1.5×10*9/L, platelet count ≥75×10*9/L, hemoglobin ≥90 g/L;
  • Liver function: Total bilirubin TBIL≤1.5×ULN (total bilirubin ≤3×ULN in Subjects with Gilbert's syndrome, liver cancer or liver metastasis), AST and ALT ≤2.5×ULN in patients without liver metastasis, AST and ALT ≤5.0×ULN in patients with liver metastasis;
  • Renal function: creatinine (Cr) ≤1.5×ULN, or creatinine clearance (Ccr) ≥50 mL/min (according to Cockcroft and Gault formula);
  • Urine routine / 24-hour protein quantification: qualitative urine protein ≤1+ (if qualitative urine protein ≥2+, 24-hour protein < 1g can be included in the group);
  • Cardiac function: left ventricular ejection fraction ≥50%;
  • Coagulation function: International standardized ratio (INR) ≤1.5×ULN, and activated partial thrombin time (APTT) ≤1.5×ULN;
  • Eligible fertile patients (male and female) must agree to use a reliable contraceptive method (hormonal or barrier method or abstinence, etc.) with their partner during the trial period and for at least 6 months after the last medication; Women of childbearing age must have a negative blood or urine pregnancy test within 7 days prior to the first use of the study drug.

Who cannot join

  • Squamous cell carcinoma with primary site of nasopharynx or skin;
  • Have received chemotherapy, radiotherapy, biotherapy, endocrine therapy, immunotherapy and other anti-tumor therapy within 4 weeks prior to the first use of the study drug, except the following:
  • Nitrosorea or mitomycin C within 6 weeks before the first administration of the study drug;
  • Oral fluorouracil and small molecule targeted drugs are 2 weeks before the first administration of the study drug or within the 5 half-lives of the drug (whichever is longer);
  • The traditional Chinese medicines with anti-tumor indications were within 2 weeks before the first use of the study drug;
  • Received an unmarketed clinical investigational drug or treatment within 4 weeks prior to the first use of the investigational drug;
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  • Has undergone major organ surgery (excluding needle biopsy, tracheotomy, gastrostomy, etc.) or has significant trauma within 4 weeks before the first use of study drugs, or needs to undergo elective surgery during the trial;
  • Previous recipients of allogeneic hematopoietic stem cell transplantation or organ transplantation;
  • A history of serious cardiovascular and cerebrovascular diseases, including but not limited to:
  • Severe cardiac rhythm or conduction abnormalities, such as ventricular arrhythmias requiring clinical intervention, grade iii atrioventricular block, etc.
  • In the resting state, QT interval was prolonged (QTc > 450 msec in men or QTc > 470 msec in women).
  • Acute coronary syndrome, congestive heart failure, aortic dissection, stroke or other grade 3 or higher cardio-cerebrovascular events within 6 months prior to the first administration;
  • New York Heart Association (NYHA) heart function grade ≥II heart failure;
  • Active autoimmune diseases and inflammatory diseases, such as: systemic lupus erythematosus, systemic treatment of psoriasis, rheumatoid arthritis, inflammatory bowel disease, and hashimoto's thyroiditis, etc., with the exception of type I diabetes, only replacement therapy can control the hypothyroidism, no systemic treatment of skin disease (e.g., vitiligo, psoriasis);
  • A history of other malignancies within 5 years prior to first administration, except for radical basal cell carcinoma of the skin, squamous cell carcinoma of the skin and/or radical excised carcinoma in place, and second primary squamous cell carcinoma of the head and neck;
  • Poorly controlled hypertension (systolic blood pressure \& GT; 150 mmHg or diastolic pressure \&gt; 100 mmHg);
  • Pulmonary disease defined as grade 3 or higher according to CTCAE V5.0; Patients with past or present interstitial lung disease (ILD);
  • Cerebral parenchymal or meningeal metastases with clinical symptoms are not suitable for inclusion by the investigator;
  • Experienced ≥ grade 3 infusion-related reactions during previous anti-EGFR antibody therapy;
  • Human immunodeficiency virus antibody (HIVAb) positive, active tuberculosis, active hepatitis B virus infection (HBV-DNA copy number > 104) or hepatitis C virus infection (HCV-RNA > center detection lower limit);
  • Active infections requiring systemic treatment, such as severe pneumonia, bacteremia, sepsis, etc.;
  • Pregnant or lactating women;
  • Persons with mental disorders or poor compliance;
  • The investigator considers that the subject has a history of other serious systemic diseases or other reasons and is not suitable to participate in this clinical study

Trial locations and contacts

3 sites in 1 country.

China3 sites

  • The Second Affiliated Hospital of Guilin Medical University

    Guilin, Guangxi

  • The Affiliated Cancer Hospital of Guizhou Medical University

    Guiyang, Guizhou

  • Shanghai Oriental Hospital

    Shanghai, Shanghai Municipality, 200000

Other trials in China

About this study

Official title: A Phase II Clinical Study to Evaluate the Efficacy and Safety of SI-B001 in the Treatment of Recurrent and Metastatic Squamous Cell Carcinoma of the Head and Neck

This multi-center, open label phase II clinical study is performed in patients with recurrent metastatic squamous cell carcinoma of the head and neck progressed on prior anti-PD-1 mab ± platinum-based chemotherapy. This study is investigating the safety and efficacy of SI-B001 as a single agent in patients.

Being tested
SI-B001
Keywords
HNSCC
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.

  • SI-B001Drug

    administration weekly by intravenous infusion（QW）.

Study groups in NCT05044897
Study groupRoleWhat they receive
Study treatmentExperimentalSI-B001 is a bispecific antibody targeting EGFR and HER3, which is administered weekly by intravenous infusion（QW）. The 4-week cycle was maintained until disease progression or cessation due to intolerable toxicity or other reasons (e.g., withdrawal of informed consent or death). From C1D1, efficacy was evaluated every 8 weeks ±7 days in the first year and every 12 weeks ±7 days in the second year.
Receives: Drug: SI-B001

What is being measured

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

  1. ORR

    Objective Response Rate

    Measured: Up to 2 weeks

Secondary outcomes (9)

  1. DOR

    Duration of Response

    Measured: Up to 2 years

  2. PFS

    Progression-free Survival

    Measured: Up to 2 years

  3. DCR

    Disease Control Rate

    Measured: Up to 2 years

  4. OS

    Overall survival

    Measured: Up to 2 years

  5. TEAE

    Treatment-Emergent Adverse Event

    Measured: Up to 2 years

  6. Tmax

    Time to maximum serum concentration

    Measured: Up to 2 years

  7. Cmax

    maximum serum concentration

    Measured: Up to 2 years

  8. Ctrough

    minimum serum concentration

    Measured: Up to 2 years

  9. ADA

    anti-SI-B001 antibody

    Measured: Up to 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 posted16 Sep 2021
  2. Study start20 Oct 2021
  3. Primary completionDec 2025 (estimated)
  4. Study completionDec 2025 (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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Masking
None (open label)
Enrolment
11 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05044897
Sponsor's protocol ID
SI-B001_209
Status last verified
Sep 2025
First submitted
22 Aug 2021
Last updated
26 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SI-B001 in people with Head and Neck Squamous Cell Carcinoma, run by Sichuan Baili Pharmaceutical Co., Ltd. at 3 sites in China.

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 21 inclusion and 24 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: under way, not looking for participants, as of the sponsor's last update on 26 Sep 2025. 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 China. 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 phase mean?

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ORR (time frame: Up to 2 weeks). 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 NCT05044897.

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 26 Sep 2025.

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