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b'Signed informed consent form; Aged 18 years and above; ECOG(Eastern Cooperative' |
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b'Oncology Group) performance is 0 or 1; Life expectancy greater than 12 weeks; Patients' |
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b'with locally advanced or metastatic malignant urothelial carcinoma which is platinum' |
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b'naive and cisplatin ineligible, or progressed after at least one line standard' |
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b'ystemic chemotherapy (including progression within 12 months of neo-/adjuvant' |
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b'therapy);' |
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b'Cisplatinum ineligible patients should meet one of the following criteria:' |
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b'Aged 70 years and above, and ECOG performance is 1;' |
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b'Serum creatinine >= 1.0xULN or CrCl\\uff1c60ml/min;' |
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b'Lose of hearing >= Grade 2;' |
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b'Peripheral nerve disorder >= Grade 2 Patients with measurable and appreciable tumor' |
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b'lesions according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1);' |
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b'Willing to provide primary lesion samples for the purpose of PD-L1 and HER2 tests.' |
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b'Adequate organ function as defined by the following criteria:' |
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b'absolute neutrophil count(ANC) >= 1.5 x 10^9/L;' |
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b'platelets>=100* 10^9/L;' |
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b'Total serum creatinine <=1.5*ULN;' |
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b'serum aspartate transaminase (AST) and serum alanine transaminase (ALT) <=2.5*upper' |
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b'limit of normal (ULN), or AST and ALT<=5*ULN if liver function abnormalities are due' |
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b'to underlying malignancy; normal serum creatinine ;' |
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b'Left ventricular ejection fraction (LVEF) \\uff1e=50%' |
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b'Hemoglobin\\uff1e=9g/dl Women of child-bearing potential and men must agree to use adequate' |
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b'contraception (e.g., condoms, implants, injectables, combined oral contraceptives,' |
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b'ome intrauterine devices [IUDs], complete sexual abstinence, or sterilized partner)' |
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b'prior to study entry and during the period of therapy and for 30 days after the last' |
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b'dose of study drug;' |
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b'Allergy to RC48-ADC, or JS001, or their components Received anti-cancer therapy'
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b'including chemotherapy, radiotherapy, immunotherapy or other clinical trial treatments'
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b'within 3 weeks of starting study treatment Unresolved toxicities from prior'
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b'anti-cancer therapy, except for alopecia Previously treated with HER2-ADC and/or'
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b'anti-PD-1 or anti-PD-L1 or anti PD-L2 therapies; Underwent major surgery within 4'
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b'weeks of first dose of study drug and not completely recovered; Received vaccine'
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b'within 4 weeks of first dose of study drug Currently active clinically significant'
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b'cardiovascular disease such as uncontrolled arrhythmia, congestive heart failure, or'
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b'greater than or equal to Class 2 congestive heart failure as defined by the New York'
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b'Heart Association Functional Classification, or history of myocardial infarction'
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b'unstable angina, or acute coronary syndrome within 6 months prior to enrollment in the'
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b'tudy; History of other neoplastic disease within 3 years prior to the study drug,'
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b'with exception of resolved/curable cancers such as basal skin cancer or squamous cell'
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b'kin cancer,.'
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b'Metastasis to CNS(central nervous system) and/or carcinomatous meningitis, with exception'
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b'for the patients who received treatment of metastasis to CNS and/or carcinomatous'
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b'meningitis and had stable disease for at least 3 months, and no evidence of progression'
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b'within 4 weeks of first dose of study treatment. No evidence of new or expanded metastasis,'
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b'and untreated with radiotherapy, surgery or steroid therapy within 4 weeks of first dose of'
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b'tudy treatment.'
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b'History of allogeneic hematopoietic stem cell transplantation or organ transplantation;'
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b'Patients who had received systemic steroid therapy within the last 2 years; Pregnancy or'
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b'lactation; Positive results of HIV testing; Active HBV(hepatitis B virus) or HCV(hepatitis'
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b'C virus) infection Active tuberculosis; Other disorders with clinical significance'
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b"according to the researcher's judgment; Unwilling or unable to participate in all required"
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b'tudy evaluations and procedures'
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