NCT05337657Unknown1 期
A Multicenter, Open-label, Phase Ib Clinical Trial of GB491 in Combination With Letrozole in Previously Untreated Patients With HR-positive, HER2-negative Advanced Breast Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- DLT
研究概览
简要总结
GB491-005 is a multicenter, open-label, phase Ib Clinical Trial study to evaluate the safety, pharmacokinetic (PK), pharmacodynamic (PD) activity, and preliminary anti-tumor activity of GB491 in combination with Letrozole in Previously Untreated Patients with HR-positive, HER2-negative Advanced Breast Cancer
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
- •Females of 18 years of age or older at study screening
- •Histologically or cytologically confirmed locally advanced or advanced metastatic breast cancer that is not amenable to curative surgical resection or radiation therapy
- •The subject has been diagnosed with ER-positive breast cancer in the local laboratory
- •The subject has HER2-negative breast cancer in the local laboratory
- •Menopausal status is not limited (including Premenopausal/perimenopausal/postmenopausal state)
- •No previous systemic anti-tumor treatment for locally advanced or metastatic breast cancer;
- •According to RECIST V1.1, the patient has at least one measurable lesion that has not been irradiated by radiotherapy and can be evaluated by CT/MRI; If only bone metastases are present, there must be at least one osteolytic bone lesion that can be evaluated by CT/MRI
- •ECOG performance status of 0 or 1
- •Adequate organ and marrow function.
- •The subject of childbearing potential must use one highly effective birth control method from the total duration of the study and 6 months after the last dose of study intervention.
- •Provide informed consent
排除标准
- •Previous treatment with CDK4/6 inhibitors
- •Subjects with known hypersensitivity to any component of GB491 or Letrozole
- •Patients with disease progression or recurrence during or within 1 year after completion of previous endocrine neoadjuvant or adjuvant therapy
- •Known active, uncontrolled, or symptomatic central nervous system metastasis, carcinomatous meningitis, or clinically manifested leptomeningeal disease, cerebral edema, spinal compression or/and tumor progressive growth
- •Visceral crisis
- •Patients with skin lesion only and radiographically non-measurable at baseline
- •Persistent toxicities (CTCAE Grade ≥ 2) caused by previous anticancer therapy, excluding alopecia
- •Major surgical procedure within 4 weeks of the first dose of study treatment or an anticipated need for major surgery, chemotherapy, radiotherapy, any other investigational drug or other anti-cancer therapy during the study
- •Patients who have been on bisphosphonates and denosumab therapy at a stable dose for less than 14 days prior to randomization
- •Patients who have received limited field radiotherapy in 2 weeks or extended field radiotherapy in 4 weeks before randomization or radiation with more than 30% of the bone marrow
- •Subjects use drugs or fruits containing strong inducers or inhibitors of CYP3A4/5, or drugs with narrow therapeutic window that are mainly metabolized by CYP3A4/5 in 14 days before randomization
- •Patients with long-term systematic use of corticosteroids
- •Any severe and/or uncontrollable medical conditions
- •Patients with severely impaired lung function
- •Known history of HIV infection or history of HIV seropositivity
- •Resting QTcF > 480 msec or there is a medical history of QTcF prolongation
- •Subjects have significant hepatic disease
- •Coagulation abnormalities
- •Refractory nausea and vomiting, inability to swallow the formulated product, or other disease or clinical status would preclude adequate absorption, distribution, metabolism, or excretion of GB491
- •Previous allogeneic bone marrow transplant
- •Inflammatory breast cancer;
- •Subjects with a history of other primary malignancies, except for non-melanoma skin cancer and cervical cancer in situ disease-free status ≥ 3 years
- •Lactating women
- •Unlikely to comply with study procedures, restrictions, and requirements
- •Judgment by the investigator that the patient should not participate into the study
研究组 & 干预措施
GB491+Letrozole
Experimental
干预措施: GB491+Letrozole (Drug)
结局指标
主要结局
DLT
时间窗: During Cycle 1 (up to 28 days)
Number of Participants with Dose-Limiting Toxicities for GB491 in Combination with Letrozole
AE
时间窗: From Baseline until 30 days after the last treatment
Number of Participants with Adverse Events by Severity, According to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI-CTCAE v5.0)
次要结局
- PFS(Approximately 2 years)
- ORR(Approximately 2 years)
- DOR(Approximately 2 years)
- DCR(Approximately 2 years)
- CBR(Approximately 2 years)
- Plasma Concentration of GB491(At predefined intervals from Cycle 1, Day 1 & Day 15; Cycle 2, Day 1 (each cycle is 28 days))
- Plasma Concentration of Letrozole(At predefined intervals from Cycle 1, Day 1 & Day 15; Cycle 2, Day 1 (each cycle is 28 days))
研究者
研究点 (1)
Loading locations...
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