Squamous Cell Carcinoma of Head and NeckPhase 1/2NCT05668858

A Study of SI-B001+SI-B003± Chemotherapy in Patients With Locally Advanced or Metastatic Head and Neck Squamous Cell Carcinoma

A Phase 1/2 study testing SI-B001 and SI-B003 in people with Squamous Cell Carcinoma of Head and Neck, 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

Phase Ib: To observe the safety and tolerability of SI-B001+SI-B003 in combination and to identify RP2D in locally advanced or metastatic head and neck squamous cell carcinoma indications. Initial efficacy, pharmacokinetic characteristics and immunogenicity were evaluated. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Squamous Cell Carcinoma of Head and Neck
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: 70 participants
Where: 1 siteChina
Study dates: 10 Feb 2023to Dec 2027
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 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Voluntarily sign the informed consent form and comply with the protocol requirements;
No gender restrictions;
Age ≥18 years and ≤75 years;
Expected survival time ≥3 months;
Histologically or cytologically confirmed head and neck squamous cell carcinoma occurring only in the oral cavity, oropharynx, hypopharynx, and larynx;
Agree to provide archived tumor tissue specimens or fresh tissue samples from primary or metastatic lesions;

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Must have at least one measurable lesion as defined by RECIST v1.1;
Performance status score: ECOG ≤1;
Toxicity from prior anti-tumor therapy has recovered to ≤ Grade 1 as defined by NCI-CTCAE v5.0;
No severe cardiac dysfunction, with left ventricular ejection fraction (LVEF) ≥50%;
Organ function levels must meet the requirements;
Coagulation function: International Normalized Ratio (INR) ≤1.5, and activated partial thromboplastin time (APTT) ≤1.5 × ULN;
Urine protein ≤1+ or ≤1000 mg/24h;
Female subjects of childbearing potential or male subjects with partners of childbearing potential must use highly effective contraception from 7 days before the first dose until 24 weeks after the last dose. Female subjects of childbearing potential must have a negative serum pregnancy test within 7 days before the first dose.

Who cannot join

Squamous cell carcinoma originating from the nasopharynx, salivary glands, nasal sinuses, skin, or with an unknown primary site;
For Phase II patients, either: a) those suitable for and willing to undergo local therapy; or b) those who have received systemic chemotherapy, excluding chemotherapy administered as part of multimodal treatment for locally advanced disease;
Patients with central nervous system (CNS) metastases and/or carcinomatous meningitis (leptomeningeal metastases) and/or spinal cord compression;
Participation in any other clinical trial within 4 weeks prior to the administration of this trial's investigational product (based on the last dose date);
Receipt of chemotherapy, radiotherapy, biological therapy, endocrine therapy, immunotherapy, or other antitumor treatments within 4 weeks before the first dose of the study drug;
Major surgery (as defined by the investigator) within 4 weeks prior to the first dose;

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Requirement for systemic corticosteroids or immunosuppressive therapy within 2 weeks before the study drug administration;
Pulmonary diseases graded as ≥Grade 3 according to NCI-CTCAE v5.0; current or history of interstitial lung disease (ILD);
Active infection requiring intravenous anti-infective therapy;
Prior immunotherapy leading to ≥Grade 3 immune-related adverse events (irAE) or ≥Grade 2 immune-related myocarditis;
Use of live attenuated vaccines within 4 weeks before the first dose of the study drug;
Use of immunomodulatory drugs (including but not limited to thymosin, interleukin-2, interferon, etc.) within 14 days before the first dose of the study drug;
Patients at risk of active autoimmune diseases or with a history of autoimmune diseases;
History of other malignancies within 5 years before the first dose;
Positive for human immunodeficiency virus (HIV) antibodies, active tuberculosis, active hepatitis B virus (HBV) infection, or hepatitis C virus (HCV) infection;
Poorly controlled hypertension (systolic blood pressure >150 mmHg or diastolic blood pressure >100 mmHg);
History of severe cardiovascular or cerebrovascular diseases;
Previous allogeneic stem cell, bone marrow, or organ transplantation;
Patients with significant serous cavity effusion, symptomatic effusion, or poorly controlled effusion;
History of hypersensitivity to recombinant humanized antibodies or any excipients of SI-B001 or SI-B003;
History of severe infusion reactions (CTCAE Grade ≥3) to antibody therapy;
History of autologous or allogeneic stem cell transplantation;
Pregnant or lactating women;
Any other condition deemed unsuitable for participation in this clinical trial by the investigator.

Trial locations and contacts

1 site in 1 country.

China1 site

Shanghai Oriental Hospital
Shanghai, Shanghai Municipality, 200000

Other trials in China

About this study

Official title: A Phase Ib/II Clinical Study of SI-B001+SI-B003 Dual-drug No-combination or Combined Chemotherapy in Patients With Locally Advanced or Metastatic Head and Neck Squamous Cell Carcinoma

Read the detailed description

Phase Ib: To observe the safety and tolerability of SI-B001+SI-B003 combination and to determine the recommended dose (RP2D) for Phase II clinical studies in locally advanced or metastatic head and neck squamous cell carcinoma indications. To evaluate the initial efficacy, pharmacokinetic characteristics and immunogenicity of SI-B001+SI-B003 in patients with locally advanced or metastatic head and neck squamous cell carcinoma. Phase II: To evaluate the efficacy of SI-B001+SI-B003 dual-agent chemotherapy in patients with locally advanced or metastatic head and neck squamous cell carcinoma. The safety, tolerability, PK/PD and immunogenicity of SI-B001+SI-B003 combined chemotherapy in patients with locally advanced or metastatic head and neck squamous cell carcinoma were evaluated.

Conditions: Squamous Cell Carcinoma of Head and Neck
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 NCT05668858
Study group	Role	What they receive
Study treatment	Experimental	Participants will receive treatment during the first cycle. Participants with clinical benefits received more cycles of additional therapy. Administration will be discontinued due to disease progression or occurrence of intolerable toxicity or other reasons. Receives: Drug: SI-B001; Drug: SI-B003

What is being measured

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

Phase Ib: Recommended Phase II Dose (RP2D)
The RP2D is defined as the dose level chosen by the sponsor (in consultation with the investigators) for phase II study, based on safety, tolerability, efficacy, PK, and PD data collected during the dose escalation study of SI-B001+SI-B003.
Measured: Up to approximately 24 months
Phase Ib: 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
Phase Ib: Dose Limited Toxicity (DLT)
The incidence and severity of adverse events (TEAE) during treatment were graded according to the National Cancer Institute Standard for Common Terminology for Adverse Events (NCI-CTCAE, v5.0).
Measured: Up to approximately 24 months
Phase Ib: Maximum Tolerated dose (MTD) or maximum administered dose (MAD)
In the dose increment stage, the highest dose whose estimated DLT rate is closest to the target DLT rate but does not exceed the upper bound of the equivalent interval of DLT rate is selected as MTD.
Measured: Up to approximately 24 months
Phase II: 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 (12)

Phase Ib/II: 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
Phase Ib/II: 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
Phase Ib/II: 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
Phase Ib/II: 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
Phase Ib/II: Cmax
Maximum serum concentration (Cmax) of SI-B001+SI-B003 will be investigated.
Measured: Up to approximately 24 months
Phase Ib/II: Tmax
Time to maximum serum concentration (Tmax) of SI-B001+SI-B003 will be investigated.
Measured: Up to approximately 24 months
Phase Ib/II: T1/2
Half-life (T1/2) of SI-B001+SI-B003 will be investigated.
Measured: Up to approximately 24 months
Phase Ib/II: AUC0-t
Blood concentration - Area under time line.
Measured: Up to approximately 24 months
Phase Ib/II: CL
To study the serum clearance rate of SI-B001+SI-B003 per unit time.
Measured: Up to approximately 24 months
Phase Ib/II: 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
Phase Ib/II: Anti-drug antibody (ADA)
Frequency and titer of anti-SI-B001, SI-B003 antibody (ADA) will be evaluated.
Measured: Up to approximately 24 months
Phase Ib/II: Neutralizing antibody (Nab)
Incidence and titer of Nab of SI-B001 and SI-B003 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.

10 Feb 2023Dec 2027

First posted30 Dec 2022
Study start10 Feb 2023
Primary completionDec 2026 (estimated)
Study completionDec 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Squamous Cell Carcinoma of Head and NeckStudies of the same condition, open and under way.
More trials run by Sichuan Baili Pharmaceutical Co., Ltd.The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: 70 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05668858
Sponsor's protocol ID: SI-B001-SI-B003-201
Status last verified: Aug 2026
First submitted: 9 Dec 2022
Last updated: 28 Aug 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Squamous Cell Carcinoma of Head and Neck trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase Ib/II Clinical Study of SI-B001+SI-B003 Dual-drug No-combination or Combined Chemotherapy in Patients With Locally Advanced or Metastatic Head and Neck Squamous Cell Carcinoma
ClinicalTrials.gov ID: NCT05668858
Acronym / sponsor ID: SI-B001-SI-B003-201
Conditions: Squamous Cell Carcinoma of Head and Neck
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 70 participants (actual)
Lead sponsor: Sichuan Baili Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
Study start: 10 Feb 2023 (actual)
Primary completion: Dec 2026 (estimated)
Study completion: Dec 2027 (estimated)
First posted: 30 Dec 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Study treatment	Experimental	Drug: SI-B001, Drug: SI-B003Participants will receive treatment during the first cycle. Participants with clinical benefits received more cycles of additional therapy. Administration will be discontinued due to disease progression or occurrence of intolerable toxicity or other reasons.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (14 listed)

Voluntarily sign the informed consent form and comply with the protocol requirements;
No gender restrictions;
Age ≥18 years and ≤75 years;
Expected survival time ≥3 months;
Histologically or cytologically confirmed head and neck squamous cell carcinoma occurring only in the oral cavity, oropharynx, hypopharynx, and larynx;

Key exclusion criteria (24 listed)

Squamous cell carcinoma originating from the nasopharynx, salivary glands, nasal sinuses, skin, or with an unknown primary site;
For Phase II patients, either: a) those suitable for and willing to undergo local therapy; or b) those who have received systemic chemotherapy, excluding chemotherapy administered as part of multimodal treatment for locally advanced disease;
Patients with central nervous system (CNS) metastases and/or carcinomatous meningitis (leptomeningeal metastases) and/or spinal cord compression;
Participation in any other clinical trial within 4 weeks prior to the administration of this trial's investigational product (based on the last dose date);
Receipt of chemotherapy, radiotherapy, biological therapy, endocrine therapy, immunotherapy, or other antitumor treatments within 4 weeks before the first dose of the study drug;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SI-B001Administration by intravenous infusion	Drug	Study treatment
SI-B003Administration by intravenous infusion	Drug	Study treatment

Primary outcome

Phase Ib: Recommended Phase II Dose (RP2D)
Time frame: Up to approximately 24 months
The RP2D is defined as the dose level chosen by the sponsor (in consultation with the investigators) for phase II study, based on safety, tolerability, efficacy, PK, and PD data collected during the dose escalation study of SI-B001+SI-B003.
Phase Ib: Objective response rate (ORR)
Time frame: Up to approximately 24 months
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.
Phase Ib: Dose Limited Toxicity (DLT)
Time frame: Up to approximately 24 months
The incidence and severity of adverse events (TEAE) during treatment were graded according to the National Cancer Institute Standard for Common Terminology for Adverse Events (NCI-CTCAE, v5.0).
Phase Ib: Maximum Tolerated dose (MTD) or maximum administered dose (MAD)
Time frame: Up to approximately 24 months
In the dose increment stage, the highest dose whose estimated DLT rate is closest to the target DLT rate but does not exceed the upper bound of the equivalent interval of DLT rate is selected as MTD.
Phase II: Objective response rate (ORR)
Time frame: Up to approximately 24 months
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.

12 secondary outcomes

Phase Ib/II: Treatment-Emergent Adverse Event (TEAE)
Time frame: Up to approximately 24 months
Phase Ib/II: Disease control rate (DCR)
Time frame: Up to approximately 24 months
Phase Ib/II: Duration of response (DOR)
Time frame: Up to approximately 24 months
Phase Ib/II: Progression-free survival (PFS)
Time frame: Up to approximately 24 months
Phase Ib/II: Cmax
Time frame: Up to approximately 24 months
Phase Ib/II: Tmax
Time frame: Up to approximately 24 months
Phase Ib/II: T1/2
Time frame: Up to approximately 24 months
Phase Ib/II: AUC0-t
Time frame: Up to approximately 24 months
Phase Ib/II: CL
Time frame: Up to approximately 24 months
Phase Ib/II: Ctrough
Time frame: Up to approximately 24 months
Phase Ib/II: Anti-drug antibody (ADA)
Time frame: Up to approximately 24 months
Phase Ib/II: Neutralizing antibody (Nab)
Time frame: Up to approximately 24 months

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
Individual participant dataSharing planned: No

Related trials for Squamous Cell Carcinoma of Head and Neck

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Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Ye Guo, PHD principal investigator

Shanghai Oriental Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing SI-B001 and SI-B003 in people with Squamous Cell Carcinoma of Head and Neck, 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 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 28 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 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?

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?

Phase Ib: Recommended Phase II Dose (RP2D) (time frame: Up to approximately 24 months). The study lists 5 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 NCT05668858.

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 28 Aug 2026.