NCT07113964尚未招募2 期
QUEEN-OSCAR: A Prospective, Multicenter, Single-arm, Phase 2 Study of QL1706 in Combination With Olaparib in Previously Treated HER2-negative Breast Cancer Patients With Homologous Recombination Deficiency (HRD)
The First Affiliated Hospital with Nanjing Medical University1 个研究点 分布在 1 个国家目标入组 79 人开始时间: 2025年8月30日最近更新:
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
- 79
- 试验地点
- 1
- 主要终点
- Progression-free Survival (PFS)
研究概览
简要总结
This study will evaluate the safety and efficacy of QL1706 and Olaparib in human epidermal growth factor receptor 2 (HER2)-negative unresectable and/or metastatic breast cancer who had received 2-4 line of prior systematic therapy.
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
- •Age 18 - 75 years; Eastern Cooperative Oncology Group (ECOG) score status 0-
- •Pathologically documented HER2-negative locally advanced or metastatic breast cancer (IHC0, IHC 1+& IHC 2+/ISH-) that was hormone-receptor positive (i.e., estrogen-receptor positive, progesterone-receptor positive, or both) or was triple negative.
- •Has been treated with 2-4 previous therapy regimens for metastatic disease.
- •HRD positive confirmed, known germline and/or systemic BRCA mutation status that is predicted to be deleterious or suspected deleterious allow preferential enrolment.
- •At least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors version 1.
- •Has protocol-defined adequate bone marrow, renal, hepatic and blood clotting functions.
- •A life expectancy of at least 12 weeks.
- •Female subjects of reproductive/childbearing potential must agree to use a highly effective form of contraception or avoid intercourse during and upon completion of the study and after the last dose for at least 3 months. Negative serum or urine pregnancy test within 7 days before study enrollment, and must be a non-lactating subject.
- •Volunteer to participate in this study and sign the informed consent.
排除标准
- •Has any active autoimmune disease, which may worsen when receiving immune stimulants.
- •Prior treatment with immune checkpoint inhibitors (ICI) (anti-CTLA-4, anti-PD-1, anti-PD-L1, combined therapy anti-PD-1/PD-L1 with anti-CTLA-4) or olaparib for advanced disease.
- •Has unresolved toxicities from previous anticancer therapy.
- •Has uncontrolled or significant cardiovascular disease.
- •Discontinuation of prior anti-PD-1/PD-L1/CTLA-4 therapy due to immune-related toxicity.
- •Known history or evidence of interstitial lung disease or active non-infectious pneumonitis.
- •Has received a live vaccine vaccination within 28 days before enrolment.
- •Has a known history of human immunodeficiency virus (HIV) infection.
- •Has known history of or is positive for Hepatitis B or Hepatitis C.
- •Any severe or poorly controlled systemic disease such as poorly controlled hypertension, active bleeding susceptibility or active infection, as judged by the investigator.
- •Has untreated or clinically active central nervous system metastases.
- •Female subjects who are pregnant, lactating or plan to become pregnant during the study.
- •Has any other condition that per protocol or in the opinion of the investigator is inappropriate for the study.
研究组 & 干预措施
Experimental:QL1706 + olaparib
Experimental
干预措施: QL1706 + olaparib (Drug)
结局指标
主要结局
Progression-free Survival (PFS)
时间窗: Up to approximately 3 years
PFS is defined as the time from the participant's first dose of study treatment to the first date of either disease progression or death, whichever occurs first.
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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