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.
Cycle 1 will be for drug-drug interaction (DDI) assessment. Thereafter, participants will receive SKB264 monotherapy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
4 mg/kg, administered once every 2 weeks (Q2W) by intravenous infusion. It will be administered on Day 1 and Day 17 of Cycle 1, and from Cycle 2 onwards, on Day 1 and Day 15 of each 4-week cycle.
500 mg administered orally, twice daily (BID) from Day 14 to Day 29 of Cycle 1.
Sun Yat-sen University Cancer Center
Guangdong, Guangzhou, China
Efficacy Endpoint
Objective response rate (ORR) assessed by the investigator based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Time frame: 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
To assess the pharmacokinetic (PK) profile of SKB264
Time frame: 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
To assess the pharmacokinetic (PK) profile of SKB264
Time frame: 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
To assess the pharmacokinetic (PK) profile of SKB264
Time frame: 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
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