This is a multicenter, open-label study to evaluate the preliminary efficacy of SKB264 and the effect of clarithromycin on the PK of SKB264 in patients with ovarian epithelial cancer.
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Efficacy Endpoint
Timeframe: From the date of first administration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Maximum observed plasma concentration (Cmax)of SKB264-ADC,SKB264-TAB and free KL610023
Timeframe: The first cycle lasts for 30 days each day, and the first day of the second, third, sixth, and twelfth cycles(Starting from the second cycle, each cycle is 28 days ),up to approximately 12 months
Area under plasma/serum concentration-time curve from zero to 13 day(AUC0-13d)of SKB264-ADC,SKB264-TAB and free KL610023
Timeframe: The first cycle lasts for 30 days each day, and the first day of the second, third, sixth, and twelfth cycles(Starting from the second cycle, each cycle is 28 days ),up to approximately 12 months
Area under plasma/serum concentration-time curve from zero to infinity(AUC0-∞)of SKB264-ADC, SKB264-TAB, and free KL610023
Timeframe: The first cycle lasts for 30 days each day, and the first day of the second, third, sixth, and twelfth cycles(Starting from the second cycle, each cycle is 28 days ),up to approximately 12 months