Study to Evaluate the Preliminary Efficacy of SKB264 and the Effect of Clarithromycin on the PK o… (NCT07341100) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Study to Evaluate the Preliminary Efficacy of SKB264 and the Effect of Clarithromycin on the PK of SKB264 in OC
China20 participantsStarted 2026-01-16
Plain-language summary
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.
Who can participate
Age range
18 Years – 75 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Females, ≥ 18 and ≤ 75 years of age at the time of signing the informed consent form (ICF).
. Patients with histologically or cytologically confirmed recurrent ovarian epithelial cancer (including fallopian tube cancer or primary peritoneal cancer).
. Able to provide tumor tissue samples.
. At least one measurable lesion.
. ECOG performance status score of 0 or 1.
. Life expectancy ≥ 12 weeks.
. Adequate bone marrow, liver, kidney, and coagulation function.
. Female participants of childbearing potential must agree to use effective medical contraception from the time of signing the ICF until 6 months after the last dose.
Exclusion criteria
. Participants with local recurrence who are suitable for surgery.
. Participants who have previously undergone bone marrow radiation.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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
2
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
3
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
4
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