NCT04836663Unknown2 期
A Open-label, Multicenter Phase II Study of TQ-B3525 Tablets in Subjects With PIK3CA and/or PIK3R1/2 Gene-altered Recurrent/Metastatic Advanced Gynecologic Tumors
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 90
- 试验地点
- 5
- 主要终点
- Overall response rate (ORR) assessed by Independent Review Committee
研究概览
简要总结
This is a study to evaluate the efficacy and safety of TQ-B3525 in subjects with recurrent / metastatic advanced endometrial cancer, cervical cancer and ovarian cancer with PIK3CA and / or PIK3R1 / 2 gene-altered (mutation or amplification). Endometrial cancer, cervical cancer and ovarian cancer are divided into three cohorts, each cohort administrated TQ-B3525 tablet orally once a day.
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
- •Pathologically confirmed malignant gynecological neoplasm.
- •Has PIK3CA and/or PIK3R1/2 Gene-altered. 3.Unresectable, locally advanced recurrent and/or metastatic tumors, has at least 1 measurable lesion.
- •4.Failed with standard treatment or has no effective treatment.
- •18 years and older, Eastern Cooperative Oncology Group(ECOG) performance status score of 0 to 1, Life expectancy ≥ 3 months.
- •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 (such as intrauterine devices , contraceptives or condoms) ；No pregnant or breastfeeding women, and a negative pregnancy test are received within 7 days before the first administration.
- •7.Understood and signed an informed consent form.
排除标准
- •1.Has untreated or active central nervous system metastases. 2.Has diagnosed and/or treated additional malignancy within 3 years prior to the first administration.
- •Insufficient hematopoietic function of bone marrow.
- •Dysfunction of liver and kidney.
- •Bleeding risk.
- •Dysfunction of gastrointestinal tract. 7.Dysfunction of heart and cerebral vessels. 8.Has received PI3K, AKT, mTOR inhibitor. 9.Has participated in other clinical trails within 30 days.
- •Has received surgery, or unhealed wounds within 4 weeks before the first administration.
- •Has received organ grafting, or hematopoietic stem cell transplantation within 60 days before the first administration, or host versus graft reaction.
- •The patients required immunosuppressor, or the whole-body, or absorbable local hormone therapy for immunosuppression purposes and continued to use within 7 days before the initial administration (daily dose of glucocorticoid <10 mg, except metacortandracin or other therapeutic hormones and so on).
- •Has active infections.
- •Has human immunodeficiency virus (HIV).
- •Pregnant or lactating women.
- •Has psychotropic substances abuse or a mental disorder.
- •Has other conditions that make it inappropriate for the patient to be enrolled based on investigator's opinion.
- •Patient's compliance is inadequate.
研究组 & 干预措施
TQ-B3525 tablet
Experimental
干预措施: TQ-B3525 tablet (Drug)
结局指标
主要结局
Overall response rate (ORR) assessed by Independent Review Committee
时间窗: up to 48 weeks
Percentage of participants achieving complete response (CR) and partial response (PR) based on IRC.
次要结局
- Duration of disease remission (DOR)(up to 48 weeks)
- DOR rate (≥ 6 months) (percentage of subjects with disease remission duration ≥ 6 months)(up to 48 weeks)
- Progression-free survival (PFS)(up to 48 weeks)
- Overall survival (OS)(up to 72 weeks)
- Overall response rate (ORR) assessed by Investigator(up to 48 weeks)
- Disease control rate（DCR）(up to 48 weeks)
研究者
研究点 (5)
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