xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06006169</url>
    </required_header>
    <id_info>
      <org_study_id>BL-B01D1-SI-B003-201-03</org_study_id>
      <nct_id>NCT06006169</nct_id>
    </id_info>
    <brief_title>A Study of BL-B01D1 and BL-B01D1+SI-B003 in the Treatment of Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (Non-nasopharyngeal Carcinoma)</brief_title>
    <official_title>A Phase II Clinical Study to Evaluate the Efficacy and Safety of BL-B01D1 and BL-B01D1 + SI-B003 in the Treatment of Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (Non-nasopharyngeal Carcinoma)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Sichuan Baili Pharmaceutical Co., Ltd.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Sichuan Baili Pharmaceutical Co., Ltd.</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Primary objective: To investigate the efficacy, safety and tolerability of BL-B01D1&#xD;
        monotherapy and BL-B01D1+SI-B003 combination therapy in patients with recurrent or metastatic&#xD;
        head and neck squamous cell carcinoma (non-nasopharyngeal carcinoma), and to further explore&#xD;
        the optimal dose and modality of combination therapy.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Primary objective: To investigate the efficacy of BL-B01D1 alone or BL-B01D1 plus SI-B003 in&#xD;
        patients with recurrent or metastatic head and neck squamous cell carcinoma&#xD;
        (non-nasopharyngeal carcinoma). To investigate the safety and tolerability of BL-B01D1&#xD;
        monotherapy and BL-B01D1+SI-B003 dual agents in patients with recurrent or metastatic head&#xD;
        and neck squamous cell carcinoma (non-nasopharyngeal carcinoma), and to further explore the&#xD;
        optimal dose and mode of combination. Secondary objective: To explore the PK of&#xD;
        investigational drugs BL-B01D1 and SI-B003. To explore the immunogenicity of BL-B01D1 and&#xD;
        SI-B003. To explore drug-drug interactions (DDI).&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">September 2025</completion_date>
    <primary_completion_date type="Anticipated">September 2025</primary_completion_date>
    <phase>Phase 2</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Objective response rate (ORR)</measure>
      <time_frame>Up to approximately 24 months</time_frame>
      <description>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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Recommended Phase II Dose (RP2D)</measure>
      <time_frame>Up to approximately 24 months</time_frame>
      <description>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.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Progression-free survival (PFS)</measure>
      <time_frame>Up to approximately 24 months</time_frame>
      <description>The PFS is defined as the time from the first dose of medication to disease progression or death, whichever occurred first.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Disease control rate (DCR)</measure>
      <time_frame>Up to approximately 24 months</time_frame>
      <description>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]).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Duration of response (DOR)</measure>
      <time_frame>Up to approximately 24 months</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Treatment-Emergent Adverse Event (TEAE)</measure>
      <time_frame>Up to approximately 24 months</time_frame>
      <description>TEAE is defined as any adverse and unexpected change in body structure, function, or chemistry or any exacerbation of an existing condition (i.e., any clinically significant adverse change in frequency and/or intensity) during treatment. The type, frequency, and severity of TEAE will be assessed during treatment.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Head and Neck Squamous Cell Carcinoma</condition>
    <arm_group>
      <arm_group_label>Study treatment</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants received BL-B01D1 or BL-B01D1 + SI-B003 therapy in the first cycle (3 weeks). Participants who had a clinical benefit could receive additional cycles of additional treatment. Administration will be discontinued because of disease progression or intolerable toxicity or for other reasons.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>BL-B01D1</intervention_name>
      <description>BL-B01D1 was administered by intravenous infusion on D1, D8, or D1 in 3-week cycles.</description>
      <arm_group_label>Study treatment</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>SI-B003</intervention_name>
      <description>SI-B003 was administered intravenously every 3 weeks (Q3W).</description>
      <arm_group_label>Study treatment</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. All subjects voluntarily participated in the study and signed informed consent.&#xD;
  &#xD;
            2. Male or female aged ≥18 years and ≤75 years.&#xD;
  &#xD;
            3. Expected survival time ≥3 months.&#xD;
  &#xD;
            4. ECOG 0-1.&#xD;
  &#xD;
            5. Patients with recurrent or metastatic head and neck squamous cell carcinoma&#xD;
               (non-nasopharyngeal carcinoma) confirmed by histopathology and/or cytology:&#xD;
  &#xD;
                 1. Cohort_A, B, and Cohort_C Stage I patients who had failed or were intolerant to 1&#xD;
                    or more lines of systemic therapy for recurrent or metastatic HNSCC&#xD;
                    (non-nasopharyngeal carcinoma);&#xD;
  &#xD;
                 2. Cohort_C Stage II patients who had not received any previous systemic antitumor&#xD;
                    therapy (other than induction chemotherapy, neoadjuvant, or adjuvant therapy) for&#xD;
                    recurrent or metastatic HNSCC (non-nasopharyngeal); Treatment failure was defined&#xD;
                    as disease progression during or after systemic antitumor therapy.&#xD;
  &#xD;
               Intolerance refers to the refusal of patients to continue the original regimen due to&#xD;
               grade 3-4 adverse reactions after receiving standard treatment.&#xD;
  &#xD;
               Note: Recurrence or disease progression within 6 months after the last chemotherapy of&#xD;
               multimodal therapy was considered as the first line of treatment.&#xD;
  &#xD;
            6. Consent to provide archival tumor tissue specimens (10-12 unstained sections&#xD;
               (anti-slip) surgical specimens (thickness 4-5μm)) or fresh tissue samples from primary&#xD;
               or metastatic lesions within 3 years. If participants cannot provide tumor tissue&#xD;
               samples, they can be enrolled if they meet other inclusion and exclusion criteria&#xD;
               after the evaluation of the investigator.&#xD;
  &#xD;
            7. Must have at least one measurable lesion according to RECIST v1.1 definition; Lesions&#xD;
               that had been previously treated with radiation could be included in a measurable&#xD;
               lesion only if there was definite disease progression after radiation therapy.&#xD;
  &#xD;
            8. No blood transfusions and no use of cell growth factors and/or platelet-raising drugs&#xD;
               during the 14 days prior to the screening period must be allowed, and the organ&#xD;
               function level must meet the following criteria:&#xD;
  &#xD;
                 1. Blood routine: hemoglobin (HGB) ≥ 90g/L; Absolute neutrophil count (NEUT) ≥&#xD;
                    1.5×10 9 /L; Platelet count (PLT) ≥ 100×10 9 /L;&#xD;
  &#xD;
                 2. Renal function: creatinine (Cr) ≤1.5 ULN, or creatinine clearance (Ccr) ≥50&#xD;
                    mL/min (according to Cockcroft and Gault formula).&#xD;
  &#xD;
                 3. Liver function: total bilirubin (TBIL≤1.5 ULN), alanine aminotransferase (ALT)&#xD;
                    and aspartate aminotransferase (AST) were all ≤2.5 ULN, and AST and ALT were both&#xD;
                    ≤5.0 ULN when liver metastasis was present;&#xD;
  &#xD;
                 4. coagulation function: international normalized ratio (INR) ≤1.5 and activated&#xD;
                    partial thromboplastin time (APTT) ≤1.5ULN;&#xD;
  &#xD;
                 5. no severe cardiac dysfunction with left ventricular ejection fraction ≥50%;&#xD;
  &#xD;
                 6. proteinuria ≤2+ or ≤1000mg/24h.&#xD;
  &#xD;
            9. Toxicity of previous antineoplastic therapy has returned to ≤ grade 1 as defined by&#xD;
               NCI-CTCAE v5.0 (except for asymptomatic laboratory abnormalities such as ALP&#xD;
               elevation, hyperuricemia, and hyperglycemia, as judged by the investigator, and&#xD;
               toxicity without safety risk, such as alopecia, grade 2 peripheral neurotoxicity, or&#xD;
               decreased hemoglobin ≥90g/L, as judged by the investigator).&#xD;
  &#xD;
           10. For premenopausal women with childbearing potential, a pregnancy test must be&#xD;
               performed within 7 days before the start of treatment, the serum or urine pregnancy&#xD;
               test must be negative, and the patient must not be lactating; All enrolled patients&#xD;
               should take adequate barrier contraception during the whole treatment cycle and for 6&#xD;
               months after the end of treatment.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Prior treatment with an ADC drug with a topoisomerase I inhibitor as a toxin.&#xD;
  &#xD;
            2. Antineoplastic therapy, including chemotherapy, biologic therapy, immunotherapy,&#xD;
               definitive radiotherapy, major surgery (investigator-defined), or targeted therapy&#xD;
               (including small-molecule tyrosine kinase inhibitors), has been administered within 4&#xD;
               weeks or 5 half-life cycles (whichever is shorter) before the first dose; Oral&#xD;
               fluorouracil drugs such as S-1, capecitabine, or palliative radiotherapy within 2&#xD;
               weeks before the first dose.&#xD;
  &#xD;
            3. Non-squamous cell tissue confirmed by histopathology and/or cytology must be excluded.&#xD;
  &#xD;
            4. Cohort_C Stage II patients who had received any previous systemic therapy for&#xD;
               recurrent or metastatic HNSCC (other than induction chemotherapy, adjuvant or&#xD;
               neoadjuvant therapy) were excluded.&#xD;
  &#xD;
            5. Cohort_C with a history of immunotherapy and grade ≥3 irAE or grade ≥2 immune-related&#xD;
               myocarditis, excluded.&#xD;
  &#xD;
            6. Cohort_C cohort_c who had received immunomodulatory drugs (including but not limited&#xD;
               to thymosin, interleukin-2, interferon, etc.) within 14 days before the first dose of&#xD;
               study drug was excluded.&#xD;
  &#xD;
            7. Systemic corticosteroids (&gt; 10mg/ day of prednisone, or the equivalent of another&#xD;
               corticosteroid) are required within 2 weeks before the first dose of the study dose;&#xD;
               Exceptions were inhaled or topical corticosteroids or physiological replacement doses&#xD;
               of corticosteroids for adrenal insufficiency.&#xD;
  &#xD;
            8. A history of immunotherapy with grade ≥3 irAE or grade ≥2 immune-related myocarditis&#xD;
               must be excluded.&#xD;
  &#xD;
            9. A history of severe cardiovascular and cerebrovascular diseases, including but not&#xD;
               limited to:&#xD;
  &#xD;
                 1. severe cardiac rhythm or conduction abnormalities, such as ventricular&#xD;
                    arrhythmias or Ⅲ degree atrioventricular block requiring clinical intervention;&#xD;
  &#xD;
                 2. prolonged QT interval at rest (QTc &gt; 450 msec in men or QTc &gt; 470 msec in women);&#xD;
  &#xD;
                 3. myocardial infarction, unstable angina, cardiac angioplasty or stent&#xD;
                    implantation, coronary artery/peripheral artery bypass grafting, New York Heart&#xD;
                    Association (NYHA) class III or IV congestive heart failure, cerebrovascular&#xD;
                    accident, or transient ischemic attack within 6 months before the first dose.&#xD;
  &#xD;
           10. Active autoimmune diseases and inflammatory diseases, such as systemic lupus&#xD;
               erythematosus, psoriasis requiring systemic treatment, rheumatoid arthritis,&#xD;
               inflammatory intestinal diseases and Hashimoto's thyroiditis, etc., excluding type I&#xD;
               diabetes mellitus, hypothyroidism that can be controlled only by replacement therapy,&#xD;
               and skin diseases without systemic treatment (such as vitiligo and psoriasis).&#xD;
  &#xD;
           11. Other malignant tumors that have progressed or require treatment within 3 years before&#xD;
               the first dose, except for radical basal cell carcinoma of the skin, squamous cell&#xD;
               carcinoma of the skin, superficial bladder cancer, radical resection of carcinoma in&#xD;
               situ, such as carcinoma in situ of the breast, prostate cancer; Notes: Patients with&#xD;
               localized low-risk prostate cancer (defined as stage ≤T2a, Gleason score ≤6, and PSA &lt;&#xD;
               10ng/mL at prostate cancer diagnosis (as measured) who had received radical treatment&#xD;
               and no biochemical recurrence of prostate specific antigen (PSA) were eligible to&#xD;
               participate in this study).&#xD;
  &#xD;
           12. A history of (non-infectious) interstitial lung disease (ILD)/pulmonary inflammation&#xD;
               requiring steroid treatment, or current ILD/ pulmonary inflammation, or suspected ILD/&#xD;
               pulmonary inflammation that cannot be ruled out by imaging at screening.&#xD;
  &#xD;
           13. Before starting the study treatment, there are:&#xD;
  &#xD;
                 1. Poorly controlled diabetes (fasting blood glucose ≥ 13.3 mmol/L)&#xD;
  &#xD;
                 2. Poorly controlled hypertension (systolic blood pressure ≥ 140 mmHg and/or&#xD;
                    diastolic blood pressure ≥ 90 mmHg)&#xD;
  &#xD;
                 3. History of hypertensive crisis or hypertensive encephalopathy.&#xD;
  &#xD;
           14. Unstable deep vein thrombosis, arterial thrombosis, and pulmonary embolism requiring&#xD;
               medical intervention within 6 months before screening; Infusion-related thrombosis was&#xD;
               excluded.&#xD;
  &#xD;
           15. Patients with central nervous system (CNS) metastases and/or carcinomatous meningitis&#xD;
               (meningeal metastases). Patients who had received treatment for brain metastases&#xD;
               (radiotherapy or surgery; Patients with stable brain metastases who had stopped&#xD;
               radiotherapy or surgery 28 days before the first dose were eligible. Patients with&#xD;
               cancerous meningitis (meningeal metastases) were excluded even if they were treated&#xD;
               and judged to be stable. Stable disease was defined as being asymptomatic, in stable&#xD;
               condition, and not requiring steroid therapy for more than 4 weeks before starting&#xD;
               study treatment.&#xD;
  &#xD;
           16. Patients with pleural effusion, pericardial effusion or ascites with clinical symptoms&#xD;
               or requiring repeated drainage.&#xD;
  &#xD;
           17. Patients with a history of allergy to recombinant humanized antibody or human-mouse&#xD;
               chimeric antibody or to any excipients of BL-B01D1.&#xD;
  &#xD;
           18. Prior organ transplantation or allogeneic hematopoietic stem cell transplantation&#xD;
               (Allo-HSCT).&#xD;
  &#xD;
           19. Human immunodeficiency virus antibody (HIVAb) positive, active tuberculosis, active&#xD;
               hepatitis B virus infection (HBV-DNA copy number &gt; 103 IU/ml) or active hepatitis C&#xD;
               virus infection (HCV antibody positive and HCV-RNA &gt; detection limit).&#xD;
  &#xD;
           20. Active infections requiring systemic therapy, such as severe pneumonia, bacteremia,&#xD;
               sepsis, etc.&#xD;
  &#xD;
           21. Had participated in another clinical trial within 4 weeks before the first dose&#xD;
               (calculated from the time of the last dose).&#xD;
  &#xD;
           22. Persons with a history of psychotropic drug abuse and inability to quit or mental&#xD;
               disorders.&#xD;
  &#xD;
           23. Other circumstances considered by the investigator to be inappropriate for&#xD;
               participation in the trial.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Chaosu Hu</last_name>
      <role>Principal Investigator</role>
      <affiliation>Fudan University</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Dongmei Ji</last_name>
      <role>Principal Investigator</role>
      <affiliation>Fudan University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Hai Zhu, PHD</last_name>
      <phone>+8613980051002</phone>
      <email>zhuhai@baili-pharm.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Sa Xiao, PHD</last_name>
      <phone>+8615013238943</phone>
      <email>xiaosa@baili-pharm.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Fudan University Shanghai Cancer Center</name>
        <address>
          <city>Shanghai</city>
          <state>Shanghai</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Chaosu Hu</last_name>
      </contact>
      <contact_backup>
        <last_name>Dongmei Ji</last_name>
      </contact_backup>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 17, 2023</study_first_submitted>
    <study_first_submitted_qc>August 17, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 23, 2023</study_first_posted>
    <last_update_submitted>August 17, 2023</last_update_submitted>
    <last_update_submitted_qc>August 17, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 23, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Non-nasopharyngeal carcinoma</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Carcinoma</mesh_term>
      <mesh_term>Carcinoma, Squamous Cell</mesh_term>
      <mesh_term>Squamous Cell Carcinoma of Head and Neck</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06006169
  org study id: BL-B01D1-SI-B003-201-03
  nct id: NCT06006169
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Primary objective: To investigate the efficacy, safety and tolerability of BL-B01D1
        monotherapy and BL-B01D1+SI-B003 combination therapy in patients with recurrent or metastatic
        head and neck squamous cell carcinoma (non-nasopharyngeal carcinoma), and to further explore
        the optimal dose and modality of combination therapy.
  Primary objective: To investigate the efficacy of BL-B01D1 alone or BL-B01D1 plus SI-B003 in
        patients with recurrent or metastatic head and neck squamous cell carcinoma
        (non-nasopharyngeal carcinoma). To investigate the safety and tolerability of BL-B01D1
        monotherapy and BL-B01D1+SI-B003 dual agents in patients with recurrent or metastatic head
        and neck squamous cell carcinoma (non-nasopharyngeal carcinoma), and to further explore the
        optimal dose and mode of combination. Secondary objective: To explore the PK of
        investigational drugs BL-B01D1 and SI-B003. To explore the immunogenicity of BL-B01D1 and
        SI-B003. To explore drug-drug interactions (DDI).
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Objective response rate (ORR)
  time frame: Up to approximately 24 months
  description: 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.
  measure: Recommended Phase II Dose (RP2D)
  time frame: Up to approximately 24 months
  description: 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.
  measure: Progression-free survival (PFS)
  time frame: Up to approximately 24 months
  description: The PFS is defined as the time from the first dose of medication to disease progression or death, whichever occurred first.
  measure: Disease control rate (DCR)
  time frame: Up to approximately 24 months
  description: 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]).
  measure: Duration of response (DOR)
  time frame: Up to approximately 24 months
  description: 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.
  measure: Treatment-Emergent Adverse Event (TEAE)
  time frame: Up to approximately 24 months
  description: TEAE is defined as any adverse and unexpected change in body structure, function, or chemistry or any exacerbation of an existing condition (i.e., any clinically significant adverse change in frequency and/or intensity) during treatment. The type, frequency, and severity of TEAE will be assessed during treatment.
  arm group label: Study treatment
  arm group type: Experimental
  description: Participants received BL-B01D1 or BL-B01D1 + SI-B003 therapy in the first cycle (3 weeks). Participants who had a clinical benefit could receive additional cycles of additional treatment. Administration will be discontinued because of disease progression or intolerable toxicity or for other reasons.
  intervention type: Drug
  intervention name: BL-B01D1
  description: BL-B01D1 was administered by intravenous infusion on D1, D8, or D1 in 3-week cycles.
  arm group label: Study treatment
  intervention type: Drug
  intervention name: SI-B003
  description: SI-B003 was administered intravenously every 3 weeks (Q3W).
  arm group label: Study treatment
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: No
  last name: Chaosu Hu
  role: Principal Investigator
  affiliation: Fudan University
  last name: Dongmei Ji
  role: Principal Investigator
  affiliation: Fudan University
  last name: Hai Zhu, PHD
  phone: +8613980051002
  email: zhuhai@baili-pharm.com
  last name: Sa Xiao, PHD
  phone: +8615013238943
  email: xiaosa@baili-pharm.com
  facility: 
  contact: 
  contact backup: 
  country: China
  responsible party type: Sponsor
  mesh term: Carcinoma
  mesh term: Carcinoma, Squamous Cell
  mesh term: Squamous Cell Carcinoma of Head and Neck