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Head and Neck Squamous Cell CarcinomaPhase 2NCT06668961

A Study of SI-B001+SI-B003 Combined With Platinum-based Chemotherapy as First-line Treatment in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

A Phase 2 study testing SI-B001 and SI-B003 in people with Head and Neck Squamous Cell Carcinoma, run by Sichuan Baili Pharmaceutical Co., Ltd. at 1 site 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 study is a open, multi-center phase II clinical study to explore the efficacy, safety and pharmacokinetic/pharmacodynamic characteristics of SI-B001+SI-B003 combined with platinum-based chemotherapy as first-line treatment in patients with recurrent or metastatic head and neck squamous cell carcinoma. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Head and Neck Squamous Cell Carcinoma
What is being tested?
SI-B001 and SI-B003
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
1 siteChina
Study dates
7 Nov 2024to Nov 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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Sign the informed consent form voluntarily and follow the protocol requirements;
  • Gender is not limited;
  • Age ≥18 years old and ≤75 years old;
  • Expected survival time ≥3 months;
  • Patients with recurrent or metastatic head and neck squamous cell carcinoma;
  • Consent to provide tumor tissue samples or fresh tissue samples archived from the primary or metastatic lesions within 2 years;
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  • At least one measurable lesion meeting the RECIST v1.1 definition was required;
  • Physical status score: ECOG ≤1;
  • The toxicity of previous antineoplastic therapy has returned to ≤ grade 1 as defined by NCI-CTCAE v5.0;
  • No severe cardiac dysfunction, left ventricular ejection fraction ≥50%;
  • No blood transfusion or colony-stimulating factor was allowed within 14 days before the first use of the study drug, and the organ function level must meet the requirements;
  • Coagulation function: international normalized ratio (INR) ≤1.5, and activated partial thromboplastin time (APTT) ≤1.5×ULN;
  • Urinary protein ≤1+ or ≤1000mg/24h;
  • Fertile female subjects, or male subjects with fertile partners, must use highly effective contraception from 7 days before the first dose until 24 weeks after the dose. Female subjects of childbearing potential had to have a negative serum pregnancy test within 7 days before the first dose.

Who cannot join

  • Squamous cell carcinoma of the nasopharynx, salivary gland, paranasal sinus, skin or of unknown primary site;
  • Patients with any of the following conditions were not eligible for the study: a) suitable and willing for local treatment; b) received systemic therapy, excluding treatment for locally advanced disease as part of multimodal therapy;
  • Patients with active central nervous system metastasis;
  • Who had participated in any other clinical trial within 4 weeks before the study dose;
  • Received radiotherapy within 4 weeks before the first dose of study drug;
  • Use of traditional Chinese medicine with anti-tumor indications within 2 weeks;
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  • Had undergone major surgery within 4 weeks before the first dose;
  • Systemic corticosteroids or immunosuppressive agents were required within 2 weeks before study dosing;
  • Pulmonary disease was defined as ≥ grade 3 according to NCI-CTCAE v5.0; Patients with existing or a history of interstitial lung disease (ILD);
  • Have active infection requiring intravenous anti-infective therapy;
  • Had received immunotherapy and had grade ≥3 irAE or grade ≥2 immune-related myocarditis;
  • Received live attenuated vaccine within 4 weeks before the first dose of study drug;
  • Had taken an immunomodulatory drug within 14 days before the first dose of study drug;
  • Patients at risk for active autoimmune disease or with a history of autoimmune disease;
  • Other malignant tumors within 5 years before the first administration;
  • Human immunodeficiency virus antibody positive, active tuberculosis, active hepatitis B virus infection or hepatitis C virus infection;
  • Poorly controlled hypertension;
  • Patients with poor blood glucose control before the first dose;
  • Had a history of severe cardiovascular and cerebrovascular diseases;
  • Previous history of allogeneic stem cell, bone marrow or organ transplantation;
  • Patients with massive or symptomatic effusions or poorly controlled effusions;
  • Patients with a history of allergy to recombinant humanized antibodies or to any of the excipients of SI-B001 or SI-B003;
  • Had severe infusion reactions to antibody therapy in the past;
  • Had autologous or allogeneic stem cell transplantation;
  • Pregnant or lactating women;
  • The investigator did not consider it appropriate to apply other criteria for participation in the trial.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality

Other trials in China

About this study

Official title: A Phase II Clinical Study to Evaluate the Safety and Efficacy of SI-B001+SI-B003 Combined With Platinum-based Chemotherapy (SI-B001+SI-B003+ Platinum-based Chemotherapy) as First-line Treatment in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

This study is a open, multi-center phase II clinical study to explore the efficacy, safety and pharmacokinetic/pharmacodynamic characteristics of SI-B001+SI-B003 combined with platinum-based chemotherapy as first-line treatment in patients with recurrent or metastatic head and neck squamous cell carcinoma.

Being tested
SI-B001, SI-B003
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 by intravenous infusion

  • SI-B003Drug

    Administration by intravenous infusion

Study groups in NCT06668961
Study groupRoleWhat they receive
Cohort AExperimentalParticipants will receive treatment during the first cycle. Participants with clinical benefit could receive additional treatment for more cycles. The administration will be terminated because of disease progression or intolerable toxicity occurring or other reasons.
Receives: Drug: SI-B001; Drug: SI-B003
Cohort BExperimentalParticipants will receive treatment during the first cycle. Participants with clinical benefit could receive additional treatment for more cycles. The administration will be terminated because of disease progression or intolerable toxicity occurring or other reasons.
Receives: Drug: SI-B001

What is being measured

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

  1. Objective response rate (ORR)

    ORR is defined as the percentage of participants, who has a CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions). The percentage of participants who experiences a confirmed CR or PR is according to RECIST 1.1.

    Measured: Up to approximately 24 months

Secondary outcomes (8)

  1. Progression-free survival (PFS)

    The PFS is defined as the time from the participant's first dose of SI-B001+SI-B003 to the first date of either disease progression or death, whichever occurs first.

    Measured: Up to approximately 24 months

  2. Disease control rate (DCR)

    The DCR is defined as the percentage of participants who has a CR, PR, or Stable Disease (SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease [PD: at least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD]).

    Measured: Up to approximately 24 months

  3. Duration of response (DOR)

    The DOR for a responder is defined as the time from the participant's initial objective response to the first date of either disease progression or death, whichever occurs first.

    Measured: Up to approximately 24 months

  4. Treatment-Emergent Adverse Event (TEAE)

    TEAE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally emerging, or any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition during the treatment of SI-B001+SI-B003. The type, frequency and severity of TEAE will be evaluated during the treatment of SI-B001+SI-B003.

    Measured: Up to approximately 24 months

  5. Cmax

    Maximum serum concentration (Cmax) of SI-B001+SI-B003 will be investigated.

    Measured: Up to approximately 24 months

  6. Tmax

    Time to maximum serum concentration (Tmax) of SI-B001+SI-B003 will be investigated.

    Measured: Up to approximately 24 months

  7. Ctrough

    Ctrough is defined as the lowest serum concentration of SI-B001+SI-B003 prior to the next dose will be administered.

    Measured: Up to approximately 24 months

  8. Anti-drug antibody (ADA)

    Frequency and titer of anti-SI-B001 and SI-B003 antibody (ADA) will be evaluated.

    Measured: Up to approximately 24 months

Timeline

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

  1. First posted1 Nov 2024
  2. Study start7 Nov 2024
  3. Primary completionNov 2026 (estimated)
  4. Study completionNov 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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06668961
Sponsor's protocol ID
SI-B001-SI-B003-203
Status last verified
Aug 2026
First submitted
30 Oct 2024
Last updated
27 Aug 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 and SI-B003 in people with Head and Neck Squamous Cell Carcinoma, run by Sichuan Baili Pharmaceutical Co., Ltd. at 1 site 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 14 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 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Objective response rate (ORR) (time frame: Up to approximately 24 months). 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 NCT06668961.

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 27 Aug 2026.

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