NCT04355520Unknown1 期
A Phase Ib, Single-arm, Open-label Study of TQ-B3525 Tablets Combined With Fulvestrant Injection in Subjects With HR-positive, HER2-negative and PIK3CA Mutation 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
- 42
- 试验地点
- 4
- 主要终点
- Dose-limiting toxicity (DLT)
研究概览
简要总结
This is a open-label, multicenter phase Ib study to evaluate safety and efficacy of TQ-B3525 tablets combined with fulvestrant injection in subjects with HR-positive, HER2-negative and PIK3CA mutation 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
- All
- 接受健康志愿者
- 否
入选标准
- •Histopathologically confirmed breast cancer.
- •Hormone receptor(HR) positive and human epidermal growth factor receptor-2 (HER2) negative for primary or metastatic tumors confirmed by immunohistochemistry test.
- •Agree to provide at least 10 unstained sections of tumor tissue obtained within 2 years (surgery or biopsy) for genetic mutation detection and with PIK3CA mutation positive.
- •Age ≥18 years, postmenopausal women.
- •Inoperable, locally advanced recurrent and/or metastatic tumor, and has at least one measurable lesion.
- •Inappropriate to receive radical resection or radiation therapy.
- •Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to
- •Life expectancy ≥12 weeks.
- •Male or female subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 6 months after the last dose of study.
- •Understood and signed an informed consent form.
排除标准
- •Has known untreated or active CNS metastasis. 2.Previous or co-existing cancers of a different site or histology from primary breast cancer.
- •Inadequate bone marrow hematopoiesis.
- •Abnormal liver function.
- •Renal abnormalities.
- •Has bleeding risk.
- •Gastrointestinal disorder.
- •Cardio-cerebrovascular anomaly.
- •Previous treatment: A) Has received fulvestrant injection; B) Has received PI3K, AKT and mTOR inhibitors; C) Has received anti-tumor treatment, including chemotherapy, radiotherapy, hormone therapy, biotherapy, immunotherapy, and surgical treatment, less than 4 weeks after the first administration; D) Has received oral targeted drugs less than 5 half-lives to the first administration; E) Has received palliative radiotherapy for non-target lesions within 2 weeks before the first administration; F) Toxicity related to previous anti-tumor treatment did not recover to ≤ grade 1, except for hair loss.
- •10.Has participated in other clinical trials within 30 days. 11.Has received major surgical treatment within 1 month or unhealed traumatic injury.
- •Has a history of organ transplantation or hematopoietic stem cell transplantation within 60 days prior to the first administration.
- •13.Immunosuppressant or systemic or absorbable local hormone therapy is required to achieve the aim of immunosuppression (dose > 10mg/ day prednisone or other therapeutic hormones) and is still used within 2 weeks after the first administration.
- •14.Active bacterial or fungal infections diseases. 15.Human immunodeficiency virus (HIV) infection. 16.Pregnant or lactating female patients. 17.Has mental and neurological diseases.
- •With severe or poorly controlled diseases.
- •Has a history of active tuberculosis.
- •Patients have inadequate compliance to participate in this study.
研究组 & 干预措施
TQ-B3525 tablets combined with fulvestrant injection
Experimental
TQ-B3525 tablets were taken orally, once daily in 28-day cycle; fulvestrant injection 500mg administered intravenously (IV) on day 1, day 15 of first cycle and on day 1 of follow-up treatment cycle. Each cycle is 28 days.
干预措施: TQ-B3525 (Drug)
TQ-B3525 tablets combined with fulvestrant injection
Experimental
TQ-B3525 tablets were taken orally, once daily in 28-day cycle; fulvestrant injection 500mg administered intravenously (IV) on day 1, day 15 of first cycle and on day 1 of follow-up treatment cycle. Each cycle is 28 days.
干预措施: Fulvestrant injection (Drug)
结局指标
主要结局
Dose-limiting toxicity (DLT)
时间窗: up to 28 days
Subjects appear the toxic reaction relate to the drug after treatment within 28 days.
次要结局
- Cmax(Hour 0, 0.5, 1, 2, 3, 4, 6, 8, 11, 24 hours post-dose on day 1; Hour 0 of day 15; and hour 0, 0.5, 1, 2, 3, 4, 6, 8, 11, 24 hours post-dose on day 28.)
- Tmax(Hour 0, 0.5, 1, 2, 3, 4, 6, 8, 11, 24 hours post-dose on day 1; Hour 0 of day 15; and hour 0, 0.5, 1, 2, 3, 4, 6, 8, 11, 24 hours post-dose on day 28.)
- Duration of Response (DOR)(up to 72 weeks)
- Overall survival (OS)(up to 72 weeks)
- Overall response rate (ORR) assessed by investigator(up to 72 weeks)
- Progression-free survival (PFS)(up to 72 weeks)
- Disease control rate（DCR）(up to 72 weeks)
- AUC0-t(Hour 0, 0.5, 1, 2, 3, 4, 6, 8, 11, 24 hours post-dose on day 1; Hour 0 of day 15; and hour 0, 0.5, 1, 2, 3, 4, 6, 8, 11, 24 hours post-dose on day 28.)
研究者
研究点 (4)
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