A Phase IIa Study to Evaluate the Efficacy and Safety of NBQ72S in Breast Cancer Patients With Leptomeningeal Metastases, With or Without Brain Parenchymal Metastases
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- OS
研究概览
简要总结
A phase IIa, single-arm, open-label study was conducted to evaluate the efficacy and safety of NBQ72S, in patients with leptomeningeal metastases from breast cancer. All patients will receive the study drug every 28 days until withdrawal from treatment.
详细描述
This is a single-arm, open-label study designed to evaluate the efficacy and safety of NBQ72S in patients with breast cancer leptomeningeal metastasis (with or without brain parenchymal metastasis).
Patients will undergo screening prior to study entry. After screening successfully, they will receive intravenous infusion of NBQ72S. Treatment will continue until disease progression, unacceptable toxicity, withdrawal of informed consent, or any other conditions except as specified in the protocol (whichever occurs first). However, patients who demonstrate clinical benefits (despite radiological progression) with manageable toxicity, and are willing to continue receiving the NBQ72S, will be given the opportunity to continue treatment after the assessment and confirmation of Investigator.
After treatment completion, patients will undergo safety follow-up and long-term survival follow-up until death or lost to follow-up.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •The patient must have histological evidence confirming the diagnosis of breast cancer with leptomeningeal metastasis: a. Breast cancer must be diagnosed through biopsy from either the primary or metastatic sites; b. Leptomeningeal metastasis (with or without brain parenchymal metastases) must be confirmed by imaging examinations(MRI), or by positive or suspicious cerebrospinal fluid cytology; c. There is no restriction on the duration of prior systemic therapy for the primary tumor.
- •The patient's Karnofsky Performance Status (KPS) must be ≥
- •The patient must have adequate bone marrow function, including:
- •Absolute neutrophil count (ANC) ≥1,500/mm³ or ≥1.5 x 10⁹/L;
- •Platelet count ≥100,000/mm³ or ≥100 x 10⁹/L;
- •Hemoglobin ≥9 g/dL;
- •The patient must have adequate renal function, including:
- •a. Serum creatinine ≤1.5 x upper limit of normal (ULN) or estimated creatinine clearance ≥50 mL/min. Note: In equivocal cases, a 24-hour urine collection test can be used to estimate the creatinine clearance more accurately;
- •The patient must have adequate hepatic function, including:
- •Total serum bilirubin ≤1.5 x ULN; if the tumor involves the liver, or if the patient has a history of Gilbert's syndrome, total bilirubin must be <3 x ULN;
- •Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 x ULN; if the tumor involves the liver, these values must be ≤5.0 x ULN;
- •Females of childbearing potential and males with fertile partners must agree to use effective contraception during the study and for 7 months following the last dose of study treatment;
排除标准
- •Patients with any other active malignancies unrelated to the primary tumor, except for those with basal cell carcinoma, squamous cell carcinoma, or in situ carcinoma that have been adequately treated.
- •Patients who are intolerant to any substance in the investigational product, including sulfobutylether-β-cyclodextrin, mefenamic acid, bendamustine, chloramphenicol, or any nitrogen mustard chemotherapy agents, or who have experienced a severe (Grade ≥3) allergic or hypersensitivity reaction to these substances.
- •Patients who have received a live vaccine or experimental drug within 30 days prior to Cycle 1, Day 1 (C1D1).
- •Pregnant or breastfeeding patients.
- •Any other conditions that may affect the patient's eligibility for this study in the judgment of the investigator
研究组 & 干预措施
Treatment Group
All patients reated with NBQ72S
干预措施: NBQ72S (Drug)
结局指标
主要结局
OS
时间窗: through study completion, an average of 1.5 years
Overall Survival
次要结局
- Intracrarnial PFS(through study completion, an average of 1.5 years)
- Intracrarnial DOR(through study completion, an average of 1.5 years)
- Extracrarnial ORR(through study completion, an average of 1.5 years)
- Extracrarnial PFS(through study completion, an average of 1.5 years)
- Extracrarnial DOR(through study completion, an average of 1.5 years)