Combination treatment for advanced head and neck cancer

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

This study is testing a combination of two drugs to see if they can help people with advanced head and neck cancer feel better and improve their treatment outcomes.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 130 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. (Industry-sponsored)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT05668858 on ClinicalTrials.gov

What this trial studies

This clinical study evaluates the safety and efficacy of a combination of two drugs, SI-B001 and SI-B003, in patients with locally advanced or metastatic head and neck squamous cell carcinoma. The study is divided into two phases: Phase Ib focuses on determining the recommended dose and assessing initial efficacy, while Phase II aims to evaluate the overall effectiveness of the drug combination. Patients will be monitored for safety, tolerability, pharmacokinetics, and immunogenicity throughout the study.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with confirmed locally advanced or metastatic head and neck squamous cell carcinoma who have either failed standard therapy or are intolerant to it.

Not a fit: Patients with early-stage head and neck cancer or those who have not yet undergone standard treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced head and neck cancer who have limited treatment alternatives.

How similar studies have performed: While this approach is being tested in this specific combination, similar studies have shown promise in treating head and neck cancers with novel therapies.

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.

Where this trial is running

Shanghai, Shanghai Municipality

• Shanghai Oriental Hospital — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Principal investigator: Ye Guo, PHD — Shanghai Oriental Hospital
• Study coordinator: Sa Xiao, PHD

Conditions Squamous Cell Carcinoma of Head and Neck