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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SKB264+clarithromycin | Experimental | Cycle 1 will be for drug-drug interaction (DDI) assessment participants received SKB264 and clarithromycin .Thereafter, participants will receive SKB264 monotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SKB264 | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy Endpoint | Objective response rate (ORR) assessed by the investigator based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. | 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 | 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 | 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 | 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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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen University Cancer Center | Guangdong | Guangzhou | 510050 | China |
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| ID | Term |
|---|---|
| D000077216 | Carcinoma, Ovarian Epithelial |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D017291 | Clarithromycin |
| ID | Term |
|---|---|
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 |
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| Clarithromycin | Drug | 500 mg administered orally, twice daily (BID) from Day 14 to Day 29 of Cycle 1. |
|
| D010051 |
| Ovarian Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| Organic Chemicals |