NCT06654440招募中2 期
An Open-label, Multicenter Phase II Clinical Study of SHR-A2102 for Injection in the Treatment of Advanced Gynaecological Malignancies
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Objective Response Rate (ORR)
研究概览
简要总结
The main objective of this study is to evaluate the effectiveness and safety of SHR-A2102 for participants with advanced gynaecological cancer.
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
- •Participate in the study voluntarily, sign the informed consent form.
- •Recurrent or metastatic gynecological malignancies that had failed standard treatments.
- •At least one measurable lesion (RECIST version 1.1).
- •With adequate organ functions.
- •Female participants of childbearing potential must agree to use highly effective contraception during the treatment period and for at least 7 months after the last dose of SHR-A2102，Female participants' HCG must be negative within 72 hours prior to enrollment and must be non-lactating.
- •Exclusion Criteria
- •With untreated brain metastasis or concomitant meningeal metastasis and spinal cord compression.
- •Previous or contemporaneous malignancies, unless these malignancies reached complete remission at least 5 years prior before screening and did not require or are not expected to require other treatment during the study period. Such as Cutaneous squamous cell carcinoma, cervical carcinoma in situ etc.
- •Had previously received antibody drug conjugates containing topoisomerase I inhibitors.
- •Had undergone major surgery other than a diagnosis or biopsy within 28 days prior to the first administration; undergone minor traumatic surgery within 7 days prior to first administration.
- •Known to be human immunodeficiency virus positive, active hepatitis B virus, or active hepatitis C virus.
- •Had active pulmonary tuberculosis within 1 year prior to enrolment.
- •Known to be allergic to any of the components of SHR-A
- •Were not fit to participate in this study by investigator's judgment.
排除标准
- 未提供
研究组 & 干预措施
Single Group
Experimental
干预措施: SHR-A2102 for injection (Drug)
结局指标
主要结局
Objective Response Rate (ORR)
时间窗: Radiological scans performed at baseline then every 6 weeks up to 36 weeks, then every 9 weeks thereafter,up to approximately 24 months.
Assessed by Investigator according to RECIST 1.1 criteria.
次要结局
- Duration of response (DoR)(Radiological scans performed at baseline then every 6 weeks up to 36 weeks, then every 9 weeks thereafter,up to approximately 24 months.)
- Disease control rate (DCR)(Radiological scans performed at baseline then every 6 weeks up to 36 weeks, then every 9 weeks thereafter,up to approximately 24 months.)
- Time to response (TTR)(Radiological scans performed at baseline then every 6 weeks up to 36 weeks, then every 9 weeks thereafter,up to approximately 24 months.)
- Progression free survival (PFS)(Radiological scans performed at baseline then every 6 weeks up to 36 weeks, then every 9 weeks thereafter,up to approximately 24 months.)
- Overall survival (OS)(follow up once every 60 days. Up to approximately 36 months.)
- 12 month survival rate(follow up once every 60 days. Up to approximately 24 months.)
- Adverse Events (AEs)(Up to approximately 24 months.)
- PK traits of SHR-A2102: Plasma concentrations of SHR-A2102.(Up to approximately 24 months.)
- PK traits of SHR-A2102: Plasma concentrations of SHR-A2102 metabolites.(Up to approximately 24 months.)
- ADA traits of SHR-A2102: Serum concentrations of SHR-A2102 at each planned blood collection time point.(Up to approximately 24 months.)
- Nab traits of SHR-A2102: Serum concentrations of SHR-A2102 at each planned blood collection time point.(Up to approximately 24 months.)
研究者
研究点 (1)
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