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Head and Neck Squamous Cell CarcinomaPhase 2NCT05054439

A Clinical Study of SI-B001 in Combination With Paclitaxel/Docetaxel in the Treatment of Recurrent and Metastatic HNSCC

A Phase 2 study testing SI-B001, Paclitaxel and docetaxel in people with Head and Neck Squamous Cell Carcinoma, run by Sichuan Baili Pharmaceutical Co., Ltd. at 7 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 Phase IIa study is a clinical trial to evaluate the safety and efficacy of SI-B001 in combination with paclitaxel or docetaxel in patients with recurrent or metastatic head and neck squamous cell carcinoma (non-nasopharyngeal carcinoma) who have experienced disease progression or intolerance to prior anti-PD-1… 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, Paclitaxel and docetaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
7 sitesChina
Study dates
22 Dec 2021to Dec 2026
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

  • The participants could understand and sign the informed consent form and must participate voluntarily.
  • No gender limit;
  • Age: ≥18 years old
  • 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 have failed or are intolerant to prior anti-PD-1 monotherapy ± platinum-based chemotherapy; Cohort-A: Patients with recurrent/metastatic head and neck squamous cell carcinoma (non-nasopharyngeal carcinoma) who have progressed on or are intolerant to first-line anti-PD-1/PD-L1 antibody ± platinum-based doublet chemotherapy, receiving SI-B001 in combination with paclitaxel/docetaxel in the second-line setting (patients with no prior treatment with docetaxel, paclitaxel, nab-paclitaxel, or paclitaxel liposome receive paclitaxel in combination; patients with prior docetaxel treatment receive paclitaxel in combination; patients with prior treatment with paclitaxel, nab-paclitaxel, or paclitaxel liposome receive docetaxel in combination).
  • Cohort-B: Patients with recurrent/metastatic head and neck squamous cell carcinoma (non-nasopharyngeal carcinoma) who have progressed on or are intolerant to first-line platinum-based doublet chemotherapy ± EGFR monoclonal antibody, and subsequently progressed on or are intolerant to second-line anti-PD-1/PD-L1 monoclonal antibody-containing therapy, receiving SI-B001 in combination with paclitaxel/docetaxel in the third-line setting (patients with no prior treatment with docetaxel, paclitaxel, nab-paclitaxel, or paclitaxel liposome receive paclitaxel in combination; patients with prior docetaxel treatment receive paclitaxel in combination; patients with prior treatment with paclitaxel, nab-paclitaxel, or paclitaxel liposome receive docetaxel in combination).
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  • Previously received only ≤ 2-line treatment for recurrent and metastatic squamous cell carcinoma of the head and neck;
  • Agree to provide tumor tissue samples (FFPE block or 10 unstained sections of 5μm size) or fresh tissue samples that have been archival within 1 year of primary or metastatic lesion. If the patient fails to provide them, 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;
  • Toxicity of previous antitumor therapy has returned to ≤1 as defined by NCI-CTCAE V5.0 (except for toxicity that the investigators judged to be of no safety risk, such as hair loss, grade 2 peripheral neurotoxicity, and stabilized 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 ≥100×10*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 patients (male and female) who are fertile must agree to use a reliable contraceptive method (hormonal or barrier method or abstinence, etc.) with their partner during the trial 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 of primary origin in the nasopharynx, salivary glands, paranasal sinuses, skin, or of unknown primary site;
  • 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;
  • Patients who have previously been treated with paclitaxel, nab-paclitaxel, liposomal paclitaxel, and docetaxel;
  • 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 grades 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 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 > 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;
  • Known allergies to paclitaxel or its standard pretreatments or other contraindications to products containing castor oil;
  • 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

7 sites in 1 country.

7 sites in 1 country

China7 sites

  • Hunan Cancer Hospital

    Changsha, Hunan

  • West China Hospital，Sichuan University

    Chengdu, Sichuan

  • The Second Affiliated Hospital of Guilin Medical University

    Guilin, Guangxi

  • The Affiliated Cancer Hospital of Guizhou Medical University

    Guiyang, Guizhou

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang

  • Shanghai Oriental Hospital

    Shanghai, Shanghai Municipality, 200120

  • Union Hospital Tongji Medical College， Huazhong University of Science and Technology

    Wuhan, Hubei

Other trials in China

About this study

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

This Phase IIa study is a clinical trial to evaluate the safety and efficacy of SI-B001 in combination with paclitaxel or docetaxel in patients with recurrent or metastatic head and neck squamous cell carcinoma (non-nasopharyngeal carcinoma) who have experienced disease progression or intolerance to prior anti-PD-1 monoclonal antibody therapy with or without platinum-based chemotherapy, and who have received no more than second-line treatment.

Being tested
SI-B001, Paclitaxel, docetaxel
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

    Si-b001 is administered by intravenous drip once a week (QW). The first intravenous infusion is 120 min±10min. If the infusion reaction can be tolerated during the first infusion, the subsequent infusion can be completed in 60-120 min.

  • PaclitaxelDrug

    The dosage of paclitaxel was 80mg/m2 QW. SI-B001 and paclitaxel were used on the same day. After SI-B001 infusion, paclitaxel was pretreated and injected for no less than 3 hours.

  • docetaxelDrug

    Docetaxel is administered at a dose of 35 mg/m² on Days 1, 8, and 15, with a 4-week treatment cycle. Treatment is continued until disease progression, unacceptable toxicity, or other reasons for discontinuation (such as withdrawal of informed consent or death).

Study groups in NCT05054439
Study groupRoleWhat they receive
SI-B001 combined with paclitaxel or docetaxelExperimentalSI-B001 in combination with paclitaxel or docetaxel for the treatment of recurrent metastatic head and neck squamous cell carcinoma (non-nasopharyngeal carcinoma) with disease progression or intolerance. The patient had previously received anti-PD-1 mab ± platinum-based chemotherapy. Patients' previous treatment line should be ≤2L.
Receives: Drug: SI-B001; Drug: Paclitaxel; Drug: docetaxel

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 years

Secondary outcomes (10)

  1. IRC-assessed Objective Response Rate (ORR)

    Objective response rate (ORR) is defined as the number of CR and PR in the treatment and control groups divided by the number of that group in the full analysis set (FAS).

    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. Duration of Response (DOR)

    Duration of Response (DOR) : defined as the period from the date when tumor response is first recorded to the date when objective tumor progression is first recorded or the date of death.

    Measured: Up to 2 years

  5. OS

    overall survival

    Measured: Up to 2 years

  6. TEAE

    Treatment Emergent Adverse Events

    Measured: Up to 2 years

  7. Cmax

    maximum serum concentration

    Measured: Up to 2 years

  8. Tmax

    Time to maximum serum concentration

    Measured: Up to 2 weeks

  9. Ctrough

    Minimum serum concentration

    Measured: Up to 2 years

  10. 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 posted23 Sep 2021
  2. Study start22 Dec 2021
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
45 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05054439
Sponsor's protocol ID
SI-B001_206
Status last verified
Aug 2026
First submitted
22 Aug 2021
Last updated
1 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SI-B001, Paclitaxel and docetaxel in people with Head and Neck Squamous Cell Carcinoma, run by Sichuan Baili Pharmaceutical Co., Ltd. at 7 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 19 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: under way, not looking for participants, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 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 years). 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 NCT05054439.

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 1 Sep 2026.

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