NCT07173556尚未招募1 期
Evaluation of Safety, Tolerability, Efficacy, and Pharmacokinetic Characteristics of QLC1401 Tablets Combined With CDK4/6 Inhibitors or mTOR Inhibitors in Patients With Estrogen Receptor-Positive (ER+), Human Epidermal Growth Factor Receptor 2-Negative (HER2-) Locally Advanced or Metastatic Breast Cancer: A Phase Ib/II Clinical Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 96
- 主要终点
- Safety and Tolerability (Phase Ib)
研究概览
简要总结
This study is an open-label, multicenter, Phase Ib/II clinical trial designed to evaluate the safety, tolerability, efficacy, and pharmacokinetic characteristics of QLC1401 tablets in combination with CDK4/6 inhibitors or mTOR inhibitors in patients with ER+/HER2- locally advanced or metastatic breast cancer. The study consists of two stages: a Phase Ib dose-escalation stage and a Phase II dose-expansion stage.
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
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
- •Voluntarily participate in the clinical trial, understand and sign the informed consent form, and agree to comply with the requirements specified in the protocol.
- •Age ≥ 18 years.
- •Female subjects must be postmenopausal and meet the trial requirements.
- •Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to
- •Life expectancy ≥ 3 months.
- •Histologically or cytologically confirmed breast cancer.
- •Based on the most recent biopsy results of primary or metastatic tumor tissue, immunohistochemistry (IHC) confirms ER-positive status and HER-2-negative status.
- •At least one measurable target lesion according to RECIST v1.
- •Adequate bone marrow function within 2 weeks (14 days) prior to the initiation of study treatment, without the need for transfusion or growth factor (G-CSF, EPO, TPO, etc.) support.
- •Adequate liver function.
- •Renal function: serum creatinine ≤ 1.5 × upper limit of normal (ULN) or creatinine clearance (Ccr) > 30 mL/min, with no significant electrolyte imbalances that are difficult to correct.
- •Coagulation function: International Normalized Ratio (INR) or prothrombin time (PT) and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN.
排除标准
- •Presence of symptomatic visceral disease or any other condition deemed unsuitable for endocrine therapy as per the investigator's judgment.
- •Presence of unresolved toxicities from prior therapy that have not recovered to ≤ CTCAE grade 1, excluding alopecia (any grade) or other toxicities considered by the investigator to pose no safety risk.
- •Received anti-tumor drug therapy within the specified time window prior to the first dose of the investigational drug.
- •Prior treatment with an experimental SERD or experimental ER antagonist.
- •Received radiotherapy within 4 weeks prior to the first dose of the investigational drug.
- •Used a strong CYP3A4 inhibitor within 7 days or 5 half-lives (whichever is longer) prior to the first dose.
- •Underwent major surgery within 4 weeks prior to the first dose of the investigational drug, or has not recovered from significant side effects, or has significant traumatic injury, non-healing wounds, or fractures.
- •History of other active malignancies within 5 years prior to the first dose of the investigational drug.
- •Known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
- •Inability to swallow the formulation, or gastrointestinal impairment/disease that may affect adequate absorption of the investigational drug.
- •Known clinically significant liver disease, including Child-Pugh class B or C, active viral hepatitis, or other hepatitis.
- •Current documented grade 1 or higher pneumonitis or interstitial lung disease.
- •Clinically significant pleural effusion, ascites, or pericardial effusion, defined as detectable on examination and requiring drainage within the past 2 weeks or additional medication to control symptoms.
- •Clinically significant uncontrolled cardiac disease and/or recent cardiac events.
- •History of bleeding tendency, thrombosis, or tumor embolism.
- •Planned treatment with everolimus and presence of uncontrolled diabetes despite adequate therapy.
- •Allergy to any of the investigational medicinal products or their components.
研究组 & 干预措施
QLC1401 in combination with CDK4/6 inhibitors
Experimental
干预措施: QLC1401 (Drug)
QLC1401 in combination with mTOR inhibitors
Experimental
干预措施: QLC1401 (Drug)
结局指标
主要结局
Safety and Tolerability (Phase Ib)
时间窗: Throughout phase Ib (approximately 1 year)
Types, incidence, and severity grades of AEs/SAEs and safety abnormalities, and their relationship to the investigational product; proportion of patients requiring dose adjustments or treatment discontinuation due to drug-related AEs.
Recommended phase II dose (RP2D) (Phase Ib)
时间窗: Throughout phase Ib (approximately 1 year)
RP2D will be selected upon safety, PK and efficacy data.
Objective Response Rate (ORR) (Phase II)
时间窗: From time of Informed Consent to confirmed progressive disease (approximately 1 year)
Objective Response Rate (ORR) as assessed by investigators per RECIST v1.1 criteria
次要结局
未报告次要终点
研究者
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