| Eligibility |
Inclusion Criteria:
1. Age = 18 years old and voluntarily signed the informed consent form.
2. Patients with histologically or cytologically confirmed SCCHN (primary tumor located
in the oral cavity, oropharynx, larynx or hypopharynx), with positive PD-L1
expression, and who are not suitable for local radical therapy.
3. Patients with platinum-based regimen failure, defined as:
1. . Recurrent or metastatic SCCHN with disease progression during or after
platinum-based therapy;
2. . Locally advanced head and neck carcinoma with recurrence or metastasis within 6
months after platinum-based therapy in previous multimodal therapy.
4. Previous or qualified tumor tissue samples are available for testing PD-L1.
5. Patients with oropharyngeal carcinoma should provide previous HPVp16
immunohistochemical test results, or eligible tumor tissue samples for testing HPV
status.
6. At least one measurable lesion confirmed by CT or MRI according to RECISTv1.1
(previously irradiated, progressive disease or tumor persistence = 3 months after
radiotherapy can be considered as measurable lesions).
7. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.
8. Life expectancy = 3 months.
9. Main organ function meets the following criteria within 7 days before treatment (no
medical supportive treatments such as blood component transfusion, human granulocyte
colony-stimulating factor (G-CSF), thrombopoietin (TPO), interleukin-11, and
erythropoietin (EPO) within 2 weeks before administration of the investigational
product).
Absolute neutrophil count =1.5×10^9/L Platelets =90×10^9/L Hb=90 g/L or =5.6 mmol/L
Serum creatinine = 1.5×ULN or creatinine clearance rate = 40 mL/min Total bilirubin
=1.0×ULN (= 1.5 × ULN for patients with liver metastasis or liver cancer); Alanine
aminotransferase (ALT) and aspartate aminotransferase (AST) = 1.5 × ULN ( = 2.5 × ULN
for patients with liver metastasis or liver cancer); Activated Partial Thromboplastin
Time (APTT) = 1.5×ULN, International Normalized Ratio (INR) = 1.5×ULN.
10. Women of childbearing potential (WOCBP) must have a negative serum pregnancy test
within 7 days prior to the first dose of the investigational drug. The patient and
his/her spouse must agree to take adequate contraception from signing of ICF through 6
months after last dose, during which time women should be nonlactating and men should
refrain from donating sperm.
Exclusion Criteria:
1. Histologically or cytologically confirmed recurrent or metastatic nasopharyngeal
carcinoma, SCCHN with unknown primary lesion, salivary gland carcinoma, or
non-squamous tissue carcinoma (e.g., mucosal melanoma).
2. Patients with active brain metastasis and leptomeningeal metastasis. Patients with
brain metastasis for whom there is no evidence of PD by MRI at least 8 weeks after
treatment and within 28 days before the first dose of the investigational drug can be
included; Those who do not require systemic cortisol therapy (prednisone > 10 mg/day
or equivalent) at least 2 weeks before the first dose of the investigational drug can
be included; Patients with skull base lesions without definite evidence of dural or
parenchymal brain involvement can be considered to be included only after discussion
with the sponsor's medical monitor.
3. History of other malignancies within 5 years prior to the first dose of the
investigational drug, except for the following: a. Any other invasive malignancy (for
which the patient has received adequate treatment) with disease free status lasting >
3 years, which will not affect the assessment of tumor efficacy as assessed by the
investigator; b. Cured basal cell or squamous cell skin carcinoma, superficial bladder
cancer, prostate cancer, cervical cancer, or breast cancer in situ, and other locally
curable cancers.
4. Patients with known or suspected autoimmune disease within 2 years before the first
dose of the investigational drug, except for the following: a. well-controlled type I
diabetes; b. well-controlled hypothyroidism requiring only hormone replacement
therapy; c. skin diseases (such as vitiligo, psoriasis, or alopecia) not requiring
systemic treatment; d. patients who are not expected to relapse in the absence of
external triggers.
5. Patients with an uncontrollable third space effusion (e.g. pleural effusion, ascites,
or pericardial effusion), who, in the judgment of the investigator, are not suitable
for the study.
6. Patients with a history of severe cardiovascular disease within 6 months before the
first dose of the investigational drug, including but not limited to:
1. . Severe heart rhythm or conduction abnormalities, such as ventricular arrhythmia
requiring clinical intervention and third-degree atrioventricular block;
2. . History of myocardial infarction, angina pectoris, angioplasty and coronary
artery bypass surgery;
3. . Heart failure with New York Heart Association (NYHA) Classification of Class
III and above;
4. . Poorly controlled hypertension.
7. Patients with prolonged QT/QTc interval (QTcF > 480 ms, Fridericia's formula: QTcF =
QT/RR^0.33, RR = 60/heart rate) by ECG during the screening period and/or with left
ventricular ejection fraction (LVEF) = 50% by echocardiography (ECHO) or multi-gated
acquisition (MUGA) during the screening period;
8. Patients with positive HCV antibody (+) (patients with negative HCV RNA can be
included, and anti-HCV treatment other than interferon is allowed), active hepatitis B
(patients with HBV DNA = 500 IU/mL can be included, and anti-HBV treatment other than
interferon is allowed), known HIV positive or known acquired immunodeficiency syndrome
(AIDS) during the screening period.
9. Patients who have undergone major organ surgery within 4 weeks before the first dose
of the investigational drug, or who need to undergo elective surgery during the study.
10. Patients who fail to recover from the toxic responses caused by previous anti-tumor
treatment to Grade 1 and below (CTCAE 5.0), except for the following: Grade 2
neuropathy, alopecia, hypothyroidism caused by previous anti-tumor treatment
(including hormone replacement therapy) and toxicity without safety risks as judged by
the investigator.
11. Patients who have previously received T cell costimulating drugs or drugs acting on
immune checkpoint pathways (including PD-1, PD-L1/2, CTLA-4 inhibitors, etc.).
12. Patients who have previously received other immunotherapies and experienced = Grade 3
irAE (immune-related adverse event).
13. Patients who have previously received taxanes (patients who previously received
taxane-containing induction chemotherapy and progressed after 6 months can be
included).
14. Patients who have received anti-tumor treatments such as chemotherapy, radiotherapy,
targeted therapy, immunotherapy and other clinical study drugs within 4 weeks before
the first dose of the investigational drug, and other conditions are as follows:
Local palliative radiotherapy within 2 weeks before the first dose of the
investigational drug; oral fluoropyrimidines, small molecule targeted drugs, etc.
within 2 weeks before the first dose of the investigational drug or within known 5
half-lives of the drug (whichever is longer); Traditional Chinese medicines with
anti-tumor indications within 2 weeks before the first dose of the investigational
drug.
15. Patients who have received corticosteroid (prednisone > 10 mg/day or equivalent) or
other immunosuppressive therapies within 2 weeks before the first dose of the
investigational drug, except for the following: a. use of topical, ocular,
intra-articular, intranasal and inhaled glucocorticoids; b. short-term use of
glucocorticoids for prophylaxis (such as prevention of contrast agent allergy).
16. Patients who have received live attenuated vaccine within 2 weeks before the first
dose of the investigational drug or planned to receive live attenuated vaccine during
the study period.
17. Patients who have used potent inhibitors or inducers of CYP3A4 within 2 weeks before
the first dose of the investigational drug.
18. Patients with known = Grade 3 hypersensitivity and/or contraindication to albumin or
monoclonal antibodies.
19. Other situations that the investigator considers not suitable for participating in the
clinical study, including but not limited to: the patient is complicated by severe or
uncontrolled medical conditions, which interfere with the interpretation of study
results and affect the study compliance.
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