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\. Meet all the conditions of any of the following queues |
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Queue one |
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Histologically confirmed patients with recurrent or metastatic cervical cancer who have failed at least the first-line platinum-containing standard treatment or failed concurrent radiotherapy and chemotherapy |
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Not suitable for surgery or radiotherapy |
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Queue two |
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Ovarian epithelial cancer, fallopian tube cancer or primary peritoneal cancer confirmed histologically |
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The subject has previously received a standard platinum-containing chemotherapy regimen, and at the same time meets any of the following criteria |
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Platinum-resistant relapsed patients who have undergone at least 2 lines (can contain BRCA |
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mutations or HRD-positive patients who have failed PARP inhibitors) standard treatment |
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failure (relapse or progression time and previous platinum-containing regimen last |
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chemotherapy (at least 4 cycles) The interval between time is less than 6 months); or at |
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least three lines (patients who have failed PARP inhibitors on BRCA mutations or |
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HRD-positive patients) platinum-sensitive relapsed patients who have failed standard |
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treatment (the time to relapse or progression is related to The interval between the last |
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platinum-containing chemotherapy (at least 4 cycles) is ≥ 6 months); Note: The definition |
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of recurrence or progression (meet any of the following conditions): a) There is clearly |
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recorded imaging progress; b) CA-125 continues to rise (CA-125 ≥ 2 times the upper limit of |
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normal, and it needs to be confirmed after 1 week ) With clinical symptoms or physical |
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examination suggesting disease progression |
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Queue three |
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Patients who have failed the standard treatment of at least first-line |
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Recurrent or metastatic endometrial cancer confirmed histologically |
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platinum-containing chemotherapy |
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Not suitable for surgery or radiotherapy |
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Queue four |
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Recurrent or metastatic other gynecological malignancies (vulvar cancer, vaginal |
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cancer, primary sarcoma of the gynecological reproductive system, etc.) that have |
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Not suitable for surgery or radiotherapy |
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failed standard treatments confirmed by histology |
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Voluntarily agree to participate in the research and sign an informed consent form |
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Female, age ≥18 years old |
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Expected survival period ≥ 12 weeks |
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The central laboratory confirms the expression of HER2: IHC 1+, 2+ or 3+; the |
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subject can provide specimens of the primary or metastatic tumor site for HER2 |
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detection (paraffin blocks, paraffin-embedded sections or fresh tissue sections are |
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acceptable); IHC2+ Of subjects need to be tested for FISH. Note: The scoring standard |
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for HER2 testing is determined by the central laboratory |
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With measurable lesions specified by RECIST 1.1 standard |
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ECOG physical status 0 or 1 point |
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Sufficient organ functions should meet the following criteria during the screening |
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period (the normal value is subject to the clinical trial center): Left ventricular |
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ejection fraction ≥50%; Hemoglobin ≥9g/dL; Absolute neutrophil count (ANC)≥1.5×109/L |
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Platelets ≥100 ×109/L; Serum total bilirubin ≤ 1.5 times the upper limit of normal |
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(ULN); ALT and AST≤2.5 × ULN when there is no liver metastasis, and ALT and AST≤5 × |
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ULN when there is liver metastasis; Serum creatinine≤1.5×ULN or calculate creatinine |
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clearance rate (CrCl)≥50 mL/min according to Cockcroft-Gault formula method |
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Female subjects should be surgically sterilized, post-menopausal patients, or agree |
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to use at least one medically approved contraceptive method (such as intrauterine |
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contraceptive devices, contraceptives, or condom).The blood pregnancy test must be |
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negative within 7 days before study entry, and it must be a non-lactating period |
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Willing and able to follow the trial and follow-up procedures |
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Suffering from central nervous system metastasis and/or cancerous meningitis
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Subjects who have received brain metastasis therapy may consider participating in this
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study, provided that the condition is stable for at least 3 months, no disease
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progression has been confirmed by imaging examination within 4 weeks before the first
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dose of the study, and all neurological symptoms have recovered At baseline, there is
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no evidence of new or enlarged brain metastases, and radiation, surgery, or steroid
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therapy should be discontinued at least 28 days before the first dose of study
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treatment. This exception does not include cancerous meningitis, which should be
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excluded regardless of whether the clinical condition is stable or not
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The toxicity caused by previous anti-tumor treatments has not been restored to
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CTCAE (version 5.0) 0-1 grade (except for 2nd degree alopecia)
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Major surgery has been performed within 4 weeks before the start of study
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administration and has not fully recovered
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A large amount of pleural fluid or ascites accompanied by clinical symptoms or
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requiring symptomatic treatment
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Serum virology examination (subject to the normal value of the research center): The
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HBsAg test result is positive, and the HBV DNA copy number is positive at the same
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time; HCVAb test result is positive (only if the PCR test result of HCV RNA is
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negative, it can be selected for this study); HIVAb test result is positive
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Have received live vaccines within 4 weeks before the start of the study
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administration or plan to receive any vaccines during the study period (except the new
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crown vaccination)
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Heart failure classified by the New York College of Cardiology (NYHA) as grade 3
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and above
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Severe arterial/venous thrombotic events or cardiovascular and cerebrovascular
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accidents occurred within 1 year before the study administration, such as deep vein
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thrombosis (not including asymptomatic intermuscular vein thrombosis without special
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treatment), pulmonary embolism, cerebral infarction, Cerebral hemorrhage, myocardial
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infarction, etc., except for lacunar infarction that is asymptomatic and does not
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require clinical intervention
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There are active or advanced infections that require systemic treatment, such as
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active tuberculosis
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There are systemic diseases that have not been stably controlled by researchers
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including diabetes, hypertension, liver cirrhosis, interstitial pneumonia, obstructive
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pulmonary disease, etc
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There are active autoimmune diseases requiring systemic treatment (such as
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immunomodulatory drugs, corticosteroids or immunosuppressive agents) within 2 years
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before the start of study administration, and related alternative treatments (such as
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thyroxine, insulin, or renal or Physiological corticosteroid replacement therapy for
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pituitary insufficiency)
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Suffered from other malignant tumors within 5 years before the start of study
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administration, except for the following conditions: Malignant tumors that can be
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expected to heal after treatment (including but not limited to fully treated thyroid
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cancer, cervical carcinoma in situ, basal or squamous cell skin cancer, or ductal
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carcinoma in situ treated by radical surgery)
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Have previously received allogeneic hematopoietic stem cell transplantation
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Have received other antibody-conjugated drug therapy in the past
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Those who are known to be allergic to recombinant humanized anti-HER2 monoclonal
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antibody-MMAE coupling agent drugs and their components
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Suffer from any other diseases, metabolic abnormalities, abnormal physical
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examinations or abnormal laboratory examinations. According to the judgment of the
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investigator, there is reason to suspect that the patient has a certain disease or
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condition that is not suitable for the use of the study drug, or will affect the
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interpretation of the study results , Or put the patient in a high-risk situation
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It is estimated that the compliance of patients to participate in this clinical
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study is insufficient
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