A Multicenter, Open-label Clinical Study to Evaluate the Preliminary Efficacy of SKB264 and the Effect of Clarithromycin, a Potent CYP3A Inhibitor, on the Pharmacokinetics of SKB264 in Patients With Ovarian Epithelial Cancer
概览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 20
- 主要终点
- Efficacy Endpoint
概览
简要总结
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.
详细描述
Cycle 1 will be for drug-drug interaction (DDI) assessment. Thereafter, participants will receive SKB264 monotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
- •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.
- •The participant voluntarily agrees to participate in the study, signs the ICF, and is able to comply with the protocol-specified visits and relevant procedures.
排除标准
- •Participants with local recurrence who are suitable for surgery.
- •Participants who have previously undergone bone marrow radiation.
- •Ovarian cancer, fallopian tube cancer, or primary peritoneal cancer of non-epithelial origin, or other pathological types.
- •Participants with known brain metastases.
- •History of other malignancies within 3 years before the first administration.
- •There are serious cardiovascular and cerebrovascular diseases or cardiovascular and cerebrovascular risk factors.
- •Uncontrolled systemic disease as judged by the investigator.
- •History of (non-infectious) interstitial lung disease (ILD) or non-infectious pneumonitis requiring steroid therapy.
- •Documented severe dry eye syndrome, severe meibomian gland disease and/or blepharitis, or a history of severe corneal disorder that prevents/delays corneal healing.
- •Patients with serious pulmonary function impairment due to lung disease.
研究组 & 干预措施
SKB264+clarithromycin
Cycle 1 will be for drug-drug interaction (DDI) assessment participants received SKB264 and clarithromycin .Thereafter, participants will receive SKB264 monotherapy
干预措施: SKB264 (Drug)
SKB264+clarithromycin
Cycle 1 will be for drug-drug interaction (DDI) assessment participants received SKB264 and clarithromycin .Thereafter, participants will receive SKB264 monotherapy
干预措施: Clarithromycin (Drug)
结局指标
主要结局
Efficacy Endpoint
时间窗: 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
Objective response rate (ORR) assessed by the investigator based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Maximum observed plasma concentration (Cmax)of SKB264-ADC,SKB264-TAB and free KL610023
时间窗: 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
To assess the pharmacokinetic (PK) profile of SKB264
Area under plasma/serum concentration-time curve from zero to 13 day（AUC0-13d）of SKB264-ADC,SKB264-TAB and free KL610023
时间窗: 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
To assess the pharmacokinetic (PK) profile of SKB264
Area under plasma/serum concentration-time curve from zero to infinity（AUC0-∞）of SKB264-ADC, SKB264-TAB, and free KL610023
时间窗: 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
To assess the pharmacokinetic (PK) profile of SKB264
次要结局
未报告次要终点