NCT07108309招募中2 期
A Randomized, Open-label, Comparative Clinical Study of the Efficacy, Safety, Pharmacokinetics, and Immunogenicity of BCD-236 in Combination With Chemotherapy in Patients With Relapsed and/or Metastatic Triple Negative Breast Cancer
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- Biocad
- 入组人数
- 124
- 试验地点
- 47
- 主要终点
- Overall response rate (ORR)
研究概览
简要总结
To study the efficacy, safety, pharmacokinetics and immunogenicity of BCD-236 in combination with chemotherapeutic agents (CHT) in 2nd and subsequent lines of therapy of subjects with relapsed and/or metastatic triple negative breast cancer (TNBC).
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 74 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent and the subject's ability to comply with the requirements of the Clinical Study Protocol.
- •Age ≥18 years and <75 years at the time of signing the informed consent form.
- •Histologically verified diagnosis (there are documented results of relevant studies) of TNBC: ER 0-2 points, PR 0-2 points or ER <1%, PR <1% (ASCO/CAP); HER2 (≤1+) or HER2 (2+) in the absence of amplification of the Her-2-neu gene by ISH.
- •TNBC is progressive or relapsing on or after systemic therapy.
- •The subject received at least 1 line of systemic therapy for locally advanced unresectable or metastatic TNBC, or she experienced a relapse / progressive disease during or within 6 months after completion of post-operative (adjuvant) chemotherapy.
- •Confirmed AXL expression in tumor cells according to immunohistochemistry.
- •Availability of fresh (obtained as part of screening or before its start, but after disease progression or relapse on the last line of therapy) and archival (obtained before disease progression or relapse on the last line of therapy, if available) tumor material samples suitable for immunohistochemical examination to determine AXL expression.
- •Presence of at least 1 measurable tumor lesion according to RECIST 1.
- •criteria for CIR.
- •ECOG score 0-
- •Life expectancy ≥ 4 months from the date of signing of the informed consent form in the opinion of the Investigator.
排除标准
- •Indications for radical therapy or radiotherapy (excluding minor surgery or radiation therapy for palliative purposes).
- •Active CNS metastases and/or carcinomatous meningitis. Subjects with brain metastases may participate in the study provided that the metastases have been adequately treated with surgery or radiotherapy, and if they have been clinically stable for at least 4 weeks prior to randomization (i.e. no neurological symptoms, no need for corticosteroids, and no lesions >1.5 cm) and no evidence of new or increasing CNS metastases. Patients with newly diagnosed CNS metastases during screening may not be included in the study.
研究组 & 干预措施
BCD-236 + Chemotherapy (CHT)
Experimental
Subjects will receive BCD-236 +CHT
Duration of treatment: until disease progression or intolerable toxicity or EOS
干预措施: BCD-236 (Biological)
BCD-236 + Chemotherapy (CHT)
Experimental
Subjects will receive BCD-236 +CHT
Duration of treatment: until disease progression or intolerable toxicity or EOS
干预措施: Chemotherapy (Drug)
Chemotherapy (CHT)
Active Comparator
Subjects will receive CHT.
Duration of treatment: until disease progression or intolerable toxicity or EOS
干预措施: Chemotherapy (Drug)
结局指标
主要结局
Overall response rate (ORR)
时间窗: 24 weeks
According to RECIST 1.1 criteria by the central independent review (CIR)
次要结局
- Progression-free survival (PFS)(51 and 102 weeks)
- Overall survival (OS)(102 weeks)
- Disease control rate (DCR)(24 weeks)
- Time to response(24 weeks)
- Duration of response(24 weeks)
研究者
研究点 (47)
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