NCT06211023尚未招募2 期
An Open-label, Randomized, Controlled, Phase II/III Study of SHR-A1921 With or Without Carboplatin Verus Investigator's Choice of Platinum-based Doublet Chemotherapy in Patients With Recurrent Epithelial Ovarian Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 520
- 主要终点
- Objective Response Rate Assessed by Investigator According to RECIST v1.1
研究概览
简要总结
This is an open-label, randomized, controlled, two-part study to evaluate the safety and efficacy of SHR-A1921 with or without carboplatin verus investigator's choice of platinum-based doublet chemotherapy in subjects with recurrent epithelial ovarian cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Voluntary participation and written informed consent.
- •Be able to provide fresh or archived tumour tissue.
- •Pathologically diagnosed epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer.
- •At least one measurable lesion according to RECIST v1.
- •Eastern Cooperative Oncology Group (ECOG) score: 0-
- •With a life expectancy ≥ 12 weeks.
- •Adequate bone marrow reserve and organ function.
排除标准
- •Uncontrolled pleural effusion, pericardial effusion, or abdominal effusion with clinical symptoms.
- •Previous or co-existing malignancies.
- •Has a history of non-infectious ILD/pneumonitis that required steroids, or has current ILD/pneumonitis;
- •Subjects with active hepatitis B or active hepatitis C;
- •Subjects who have received systemic anti-tumor treatments 4 weeks prior to the initiation of the study treatment.
- •Subjects who have been treated with TOP1 inhibitors, TROP-2 ADC or ADCs with TOP1 inhibitors as payload.
- •Has unresolved CTCAE ≥grade 2 toxicities from previous anticancer therapy.
研究组 & 干预措施
Treatment group 1: SHR-1921
Experimental
干预措施: SHR-1921 (Drug)
Treatment group 2: SHR-1921 + carboplatin dose level 1
Experimental
干预措施: carboplatin (Drug)
Treatment group 3: SHR-1921 + carboplatin dose level 2
Experimental
干预措施: carboplatin (Drug)
Treatment group 4: platinum-based doublet chemotherapy
Other
干预措施: platinum-based doublet chemotherapy (Drug)
结局指标
主要结局
Objective Response Rate Assessed by Investigator According to RECIST v1.1
时间窗: Screening up to study completion, an average of 1 year
次要结局
- Overall Survival (OS)(Screening up to study completion, an average of 1 year)
- CA-125 Response assessed by the Gynecologic Cancer Intergroup (GCIG) criteria(Screening up to study completion, an average of 1 year)
- Duration of Response (DoR) Assessed by Investigator as per RECIST 1.1(Screening up to study completion, an average of 1 year)
- Disease Control Rate (DCR) Assessed by Investigator as per RECIST 1.1(Screening up to study completion, an average of 1 year)
- Progression-Free Survival (PFS) Assessed by Investigator as per RECIST 1.1(Screening up to study completion, an average of 1 year)
研究者
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