NCT07235176招募中1 期
A Phase Ib/II Clinical Study to Evaluate Safety, Preliminary Efficacy and PK Characteristic of QLS1304 Combined With Endocrine Therapy in ER+/HER2- Breast Cancer Patients
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Recommended Phase II Dose (RP2D) of QLS1304 in combo therapy
研究概览
简要总结
This study is a multi-center, open label, phase Ib/II clinical trial aimed at evaluating the safety, preliminary efficacy characteristic and PK characteristics of QLS1304 in combined with endocrine therapy in ER+/HER2- breast cancer patients. This study was divided into two stages: combo dose escalation and dose expansion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- All
- 接受健康志愿者
- 否
入选标准
- •Volunteer to participate in this study, sign an informed consent form and have good compliance;
- •Age ≥ 18 years old, Male or female
- •ECOG score: 0-1
- •Expected survival ≥ 12 weeks
- •Local recurrent or metastatic advanced ER+/HER2- breast cancer confirmed by histopathology or cytopathology;
- •Failed to at least one therapy line of endocrine therapy ;
- •Baseline presence of at least one measurable lesion according to the RECIST v1.1;
- •The functional level of important organs is basically normal, meeting the requirements of the scheme;
- •Female subjects with fertility and male subjects must agree to use highly effective contraception during the study treatment period and within 180 days after the last medication;
- •Female subjects with fertility must have a negative serum HCG test within 7 days before the first medication in the study, and must be in non lactation.
- •Volunteer to participate in this clinical trial, willing and able to follow the procedures related to clinical visits and research, understand the research procedures, and have signed informed consent.
排除标准
- •Subjects have received live or attenuated live vaccines within 4 weeks before the first use of the investigational drug.
- •Subjects have undergone major organ surgery within 4 weeks before the first use of the investigational drug.
- •Subjects require long-term or high-dose use of non-steroidal drugs.
- •Subjects have not recovered from adverse events (AEs) caused by previous anti-tumor treatment to ≤ grade
- •Subjects have a known or suspected severe allergy to the investigational drug or any of its components.
- •Subjects have other active malignant tumors within 3 years before the first use of the investigational drug.
- •Subjects have brain metastases and/or carcinomatous meningitis or leptomeningeal disease.
- •Subjects have active tuberculosis, radiation pneumonitis, drug-induced pneumonitis, pulmonary fibrosis, or other diseases, symptoms, or signs of severe lung function impairment.
- •Subjects are unable to swallow tablets or had gastrointestinal abnormalities that the investigator assessed as potentially affecting drug absorption.
- •Subjects have a history of severe cardiovascular or cerebrovascular disease within 6 months before the first use of the investigational drug.
- •Subjects have a hypertension medial history that blood is not well controlled despite treatment with multiple antihypertension drugs.
研究组 & 干预措施
QLS1304 tablet + SERD
Experimental
干预措施: QLS1304 tablet+Fulvestrant or QLC1401 (Drug)
QLS1304 tablet + ET+CDK4/6i
Experimental
干预措施: QLS1304 tablet+Fulvestrant，AI or QLC1401+CDK4/6i (Drug)
结局指标
主要结局
Recommended Phase II Dose (RP2D) of QLS1304 in combo therapy
时间窗: through study completion，an average of 2 years
objective response rate（ORR）
时间窗: through study completion，an average of 2 years
次要结局
未报告次要终点
研究者
研究点 (1)
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