NCT07045311招募中2 期
JS207 Combination Therapy in Recurrent or Metastatic Triple-negative Breast Cancer(TNBC)
Shanghai Junshi Bioscience Co., Ltd.32 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2025年9月17日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 32
- 主要终点
- ORR
研究概览
简要总结
This is an open-label, multi-center, phase II clinical study to preliminarily evaluate the efficacy and safety of JS207 combined with 9MW2821 or albumin paclitaxel as first-line therapy in patients with recurrent or metastatic TNBC.
详细描述
The study consists of Cohort A and Cohort B. Both cohorts include patients with recurrent or metastatic TNBC who have not received systemic anti-tumor therapy previously. Cohort A will receive JS207 combined with 9MW2821, and Cohort B will receive JS207 combined with albumin paclitaxel. Each cohort consists of two stages: safety run-in period and cohort expansion period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
None(open label)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female age 18 - 75 years old；
- •Voluntary participation in clinical study；
- •Histologically confirmed unresectable, locally advanced or metastatic triple-negative breast cancer(absence of HER2, ER, and PR expression);
- •No prior systemic antitumor therapy for locally advanced or Metastatic TNBC；
- •Prior use of systemic anti-tumor therapy in the neoadjuvant and/or adjuvant phase is allowed, but must meet the following conditions: (1) the time interval between the end of neoadjuvant/adjuvant therapy and the occurrence of recurrence/metastasis is ≥6 months; (2) Arm2: if taxane is used in the neoadjuvant/adjuvant phase, the DFI must be ≥12 months;
- •Adequate organ function;
- •ECOG performance status of 0 or 1;
- •Life expectancy 12 weeks;
- •Measurable disease, as defined by RECIST v1.1;
排除标准
- •Untreated or active central nervous system (CNS) metastases；
- •Uncontrolled pleural effusion, pericardial effusion or ascites；
- •Tumor encasement of important vessels or significant necrosis and cavitation that may cause a risk of hemorrhage；
- •History of significant bleeding tendency or severe coagulation disorder；
- •Uncontrolled hypertension；
- •Active autoimmune diseases requiring systemic treatmen within 2 years prior to the first dose；
- •History of interstitial lung disease or previous Noninfectious pneumonitis treated with corticosteroids, or evidence of active Pneumonia in radiology on screening period；
- •Eye disorders or symptoms: severe xerophthalmia, keratoconjunctivitis sicca, severe exposure keratitis, or other conditions；
- •Severe cardiovascular disease；
- •Serious infection (CTCAE 5.0 Grade>2) within 28 days prior to the first dose of study drug；
- •Previous treatment with anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs or drugs targeting other stimulatory or co-inhibitory T cell receptors (e.g., CTLA-4, OX-40, CD137) in (new) adjuvant therapy is allowed, if DFI is ≥6 months previously treated with Antibody-Drug Conjugates conjugated with MMAE and/or targeting Nectin-4, such as Enfortumab Vedotin is not allowed；
- •History of another malignancy within 5 years before the first dose of study drug；
- •Not suitable to receive study treatment for other conditions as per investigator；
研究组 & 干预措施
Cohort A
Experimental
干预措施: JS207 in combination with 9MW2821 (Drug)
Cohort B
Experimental
干预措施: JS207 in combination with Albumin paclitaxel (Drug)
结局指标
主要结局
ORR
时间窗: 2years
Objective response rate（ORR） evaluated based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria
ORR
时间窗: 2years
Objective response rate（ORR） evaluated based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria
次要结局
- AE(2years)
- DOR(2years)
- DCR(2years)
- PFS(2years)
- OS(3years)
- Plasma concentrations(2years)
- ADA(2years)
- Nab(2years)
- PD-L1(2years)
- Nectin-4(2years)
- DOR(2years)
- DCR(2years)
- PFS(2years)
- OS(3years)
- AE(2years)
- Plasma concentrations(2years)
- ADA(2years)
- Nab(2years)
- PD-L1(2years)
研究者
研究点 (32)
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