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

NCT ID: NCT05668858

Last Updated: 2025-09-26

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 130 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-10
• Study Completion Date: 2027-12-31

Brief 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. Phase II: To evaluate the efficacy of SI-B001+SI-B003 two-drug combination chemotherapy. Safety and tolerance, PK/PD, immunogenicity were evaluated.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Study treatment

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.

Group Type: EXPERIMENTAL

SI-B001

Intervention Type: DRUG

Administration by intravenous infusion

SI-B003

Intervention Type: DRUG

Administration by intravenous infusion

Interventions

SI-B001

Administration by intravenous infusion

Intervention Type: DRUG

SI-B003

Administration by intravenous infusion

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Voluntarily sign the informed consent form and comply with the protocol requirements;

2. No gender restrictions;

3. Age ≥18 years and ≤75 years;

4. Expected survival time ≥3 months;

5. Histologically or cytologically confirmed head and neck squamous cell carcinoma occurring only in the oral cavity, oropharynx, hypopharynx, and larynx;

6. Agree to provide archived tumor tissue specimens or fresh tissue samples from primary or metastatic lesions;

7. Must have at least one measurable lesion as defined by RECIST v1.1;

8. Performance status score: ECOG ≤1;

9. Toxicity from prior anti-tumor therapy has recovered to ≤ Grade 1 as defined by NCI-CTCAE v5.0;

10. No severe cardiac dysfunction, with left ventricular ejection fraction (LVEF) ≥50%;

11. Organ function levels must meet the requirements;

12. Coagulation function: International Normalized Ratio (INR) ≤1.5, and activated partial thromboplastin time (APTT) ≤1.5 × ULN;

13. Urine protein ≤1+ or ≤1000 mg/24h;

14. 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.

Exclusion Criteria

1. Squamous cell carcinoma originating from the nasopharynx, salivary glands, nasal sinuses, skin, or with an unknown primary site;

2. 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;

3. Patients with central nervous system (CNS) metastases and/or carcinomatous meningitis (leptomeningeal metastases) and/or spinal cord compression;

4. 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);

5. Receipt of chemotherapy, radiotherapy, biological therapy, endocrine therapy, immunotherapy, or other antitumor treatments within 4 weeks before the first dose of the study drug;

6. Major surgery (as defined by the investigator) within 4 weeks prior to the first dose;

7. Requirement for systemic corticosteroids or immunosuppressive therapy within 2 weeks before the study drug administration;

8. Pulmonary diseases graded as ≥Grade 3 according to NCI-CTCAE v5.0; current or history of interstitial lung disease (ILD);

9. Active infection requiring intravenous anti-infective therapy;

10. Prior immunotherapy leading to ≥Grade 3 immune-related adverse events (irAE) or ≥Grade 2 immune-related myocarditis;

11. Use of live attenuated vaccines within 4 weeks before the first dose of the study drug;

12. 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;

13. Patients at risk of active autoimmune diseases or with a history of autoimmune diseases;

14. History of other malignancies within 5 years before the first dose;

15. Positive for human immunodeficiency virus (HIV) antibodies, active tuberculosis, active hepatitis B virus (HBV) infection, or hepatitis C virus (HCV) infection;

16. Poorly controlled hypertension (systolic blood pressure >150 mmHg or diastolic blood pressure >100 mmHg);

17. History of severe cardiovascular or cerebrovascular diseases;

18. Previous allogeneic stem cell, bone marrow, or organ transplantation;

19. Patients with significant serous cavity effusion, symptomatic effusion, or poorly controlled effusion;

20. History of hypersensitivity to recombinant humanized antibodies or any excipients of SI-B001 or SI-B003;

21. History of severe infusion reactions (CTCAE Grade ≥3) to antibody therapy;

22. History of autologous or allogeneic stem cell transplantation;

23. Pregnant or lactating women;

24. Any other condition deemed unsuitable for participation in this clinical trial by the investigator.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sichuan Baili Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ye Guo, PHD

Role: PRINCIPAL_INVESTIGATOR

Shanghai Oriental Hospital

Locations

Shanghai Oriental Hospital

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Sa Xiao, PHD

Role: CONTACT

xiaosa@baili-pharm.com

+8615013238943

Facility Contacts

Ye Guo, PHD

Role: primary

pattrickguo@gmail.com

86-21-38804518

Siwei Bao

Role: backup

siwei_bao@163.com

021-38804518-22198

Other Identifiers

SI-B001-SI-B003-201

Identifier Type: -

Identifier Source: org_study_id