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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Head and Neck Squamous Cell Carcinoma
• Intervention / Treatment: Drug: SI-B001; Drug: Paclitaxel; Drug: docetaxel

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Guangxi
    • Guilin, Guangxi, China
      • The Second Affiliated Hospital of Guilin Medical University
  • Guizhou
    • Guiyang, Guizhou, China
      • The Affiliated Cancer Hospital of Guizhou Medical University
  • Hubei
    • Wuhan, Hubei, China
      • Union Hospital Tongji Medical College， Huazhong University of Science and Technology
  • Hunan
    • Changsha, Hunan, China
      • Hunan Cancer Hospital
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200120
      • Shanghai Oriental Hospital
  • Sichuan
    • Chengdu, Sichuan, China
      • West China Hospital，Sichuan University
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • Zhejiang Cancer Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. The participants could understand and sign the informed consent form and must participate voluntarily.
2. No gender limit;
3. Age: ≥18 years old
4. 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;

5. 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).

6. Previously received only ≤ 2-line treatment for recurrent and metastatic squamous cell carcinoma of the head and neck;
7. 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;
8. 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;
9. Physical fitness ECOG score 0 or 1;
10. 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);

11. Organ function levels must meet the following requirements and meet the following standards:

    1. Bone marrow function: absolute neutrophil count (ANC)≥1.5×10*9/L, platelet count ≥100×10*9/L, hemoglobin ≥90 g/L;
    2. 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;
    3. Renal function: creatinine (Cr) ≤1.5×ULN, or creatinine clearance (Ccr) ≥50 mL/min (according to Cockcroft and Gault formula);
    4. 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);
    5. Cardiac function: left ventricular ejection fraction ≥50%;
    6. Coagulation function: International standardized ratio (INR) ≤1.5×ULN, and activated partial thrombin time (APTT) ≤1.5×ULN;
12. 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.

Exclusion Criteria:

1. Squamous cell carcinoma of primary origin in the nasopharynx, salivary glands, paranasal sinuses, skin, or of unknown primary site;

2. 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;
3. Received an unmarketed clinical investigational drug or treatment within 4 weeks prior to the first use of the investigational drug;
4. 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;
5. Patients who have previously been treated with paclitaxel, nab-paclitaxel, liposomal paclitaxel, and docetaxel;
6. Previous recipients of allogeneic hematopoietic stem cell transplantation or organ transplantation;

7. 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;
8. 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);
9. 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;
10. Poorly controlled hypertension (systolic blood pressure & GT; 150 mmHg or diastolic pressure > 100 mmHg);
11. Pulmonary disease defined as grade 3 or higher according to CTCAE V5.0; Patients with past or present interstitial lung disease (ILD);
12. Cerebral parenchymal or meningeal metastases with clinical symptoms are not suitable for inclusion by the investigator;
13. Experienced ≥ grade 3 infusion-related reactions during previous anti-EGFR antibody therapy;
14. Known allergies to paclitaxel or its standard pretreatments or other contraindications to products containing castor oil;
15. 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);
16. Active infections requiring systemic treatment, such as severe pneumonia, bacteremia, sepsis, etc.;
17. Pregnant or lactating women;
18. Persons with mental disorders or poor compliance;
19. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: SI-B001 combined with paclitaxel or docetaxel; SI-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.

Drug: SI-B001; 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.; Drug: Paclitaxel; 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.; Drug: docetaxel; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ORR	(Objective Response Rate )	Up to 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tmax	Time to maximum serum concentration	Up to 2 weeks
PFS	Progression-free Survival	Up to 2 years
DCR	Disease Control Rate	Up to 2 years
OS	overall survival	Up to 2 years
TEAE	Treatment Emergent Adverse Events	Up to 2 years
Cmax	maximum serum concentration	Up to 2 years
Ctrough	Minimum serum concentration	Up to 2 years
ADA	anti-SI-B001 antibody	Up to 2 years
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).	Up to 2 years
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.	Up to 2 years

Collaborators and Investigators

• Sponsor: Sichuan Baili Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): December 22, 2021
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: August 22, 2021
• First Submitted That Met QC Criteria: September 14, 2021
• First Posted (Actual): September 23, 2021

Study Record Updates

• Last Update Posted (Actual): September 1, 2026
• Last Update Submitted That Met QC Criteria: August 30, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: HNSCC
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Head and Neck Neoplasms; Neoplasms, Glandular and Epithelial; Carcinoma; Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck; Organic Chemicals; Hydrocarbons; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Taxoids; Cyclodecanes; Diterpenes; Docetaxel; Paclitaxel
• Other Study ID Numbers: SI-B001_206

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No