NCT05775575招募中1 期
A Phase Ib/II Study to Investigate the Safety, Tolerance and Pharmacokinetics of TQB3909 With HR-positive, HER2-negative Advanced Breast Cancer
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Maximum tolerated dose (MTD)
研究概览
简要总结
TQB3909 is an inhibitor targeting B-cell lymphoma (BCL)-2 protein. By binding to BCL-2 protein, TQB3909 releases Pro apoptotic proteins such as BCL-2-Anatagonist/Killer 1(BAK), BCL-2 associated X (BAX) protein and BCL-2 associated death (BAD) protein, promotes the release of cytochrome c from mitochondria, phosphatidylserine eversion, stimulates caspase 3/7 activity and caspase 3/9 cleavage, and induces apoptosis.
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 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study.
- •Age: 18 to 75 years old; female patient, an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to
- •Histopathologically confirmed HR positive and HER2 negative advanced or metastatic breast cancer.
- •Patients who have been treated with endocrine therapy and have experienced disease progression.
- •Patients previously treated with any CDK4/6 inhibitor and not treated with BCL-2 inhibitor.
- •Has at least one measurable lesion according to Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 criteria
- •The main organs function well;
- •Female patient had no plans to become pregnant and voluntarily took effective contraceptive measures from agree with the study to at least 6 months after the last dose of study drug.
排除标准
- •Concomitant disease and medical history:
- •There were other malignant tumors in 3 years before the first medication.
- •Has multiple factors affecting oral medication;
- •Unalleviated toxicity ≥ grade 1 due to any previous therapy;
- •Major surgical treatment, open biopsy and obvious traumatic injury were performed within 28 days before the study; e．Arteriovenous thrombotic events occurred within 6 months before the first medication, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep venous thrombosis and pulmonary embolism; f．Have a history of psychotropic drug abuse and can not quit or have mental disorders; g．Subjects with any severe and / or uncontrolled disease included: Cirrhosis, active hepatitis, history of immunodeficiency;
- •Tumor-related symptoms and treatment:
- •Has central nervous system metastases (CNS) and/or cancerous meningitis or leptomeningeal carcinomatosis;
- •have received radiotherapy, other antineoplastic therapy within 2 weeks prior to the first dose;
- •Has uncontrollable pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures.
- •Known hypersensitivity to TQB3909, LHRH agonists (e.g., goserelin), or any excipients.
- •Subjects who have received the vaccine within 28 days prior to the first dose, or are planning to receive the vaccine during the study period.
- •Has Participated in other clinical trials within 4 weeks before first dose.
- •According to the judgement of the investigators, there are other factors that may lead to the termination of the study.
研究组 & 干预措施
TQB3909 tablets
Experimental
200-1000mg of TQB3909 tablets once a day; Oral administration under fast condition, 28 days as a cycle.
干预措施: TQB3909 tablets (Drug)
结局指标
主要结局
Maximum tolerated dose (MTD)
时间窗: At the end of Cycle 1 (Cycle 1, Day 28)
MTD was defined as the highest dose at which dose-limiting toxicity (DLT) occurred in less than 33% of patients.
Dose Limiting Toxicity (DLT)
时间窗: At the end of Cycle 1 (Cycle 1, Day 28)
DLT will be defined as toxicities that meet pre-defined severity criteria(according to the NCI CTCAE v5.0 toxicity assessment criteria), and assessed as having a suspected relationship to study drug that occurred from the first dose to the end of the first treatment cycle.
Recommended Phase II Dose (RP2D)
时间窗: Baseline up to 24 months
DLT describes side effects of a drug or other treatment that are serious enough to evaluate RP2D of TQB3909 tablets in adult patients with Breast cancers
次要结局
- Time to reach maximum (peak)plasma concentration (Tmax)(before administration at Day 1, Cycle1 Day7,Cycle1 Day14, Cycle1 Day28; 1, 2, 4, 6, 8, 10,24,48, and 72 hours after-dose at Day 1; 1, 2, 4, 6, 8, 10, and 24 hours after-dose at Cycle 1 Day 28.)
- Maximum (peak) steady-state plasma drug concentration during a dosage interval (Cmax,ss)(before administration at Day 1, Cycle1 Day7,Cycle1 Day14, Cycle1 Day28; 1, 2, 4, 6, 8, 10,24,48, and 72 hours after-dose at Day 1; 1, 2, 4, 6, 8, 10, and 24 hours after-dose at Cycle 1 Day 28.)
- Area under the plasma concentration-time curve from time zero to time t (AUC0-t)(before administration at Day 1, Cycle1 Day7,Cycle1 Day14, Cycle1 Day28; 1, 2, 4, 6, 8, 10,24,48, and 72 hours after-dose at Day 1; 1, 2, 4, 6, 8, 10, and 24 hours after-dose at Cycle 1 Day 28.)
- Minimum steady-state plasma drug concentration during a dosage interval (Cmin,ss)(before administration at Day 1, Cycle1 Day7,Cycle1 Day14, Cycle1 Day28; 1, 2, 4, 6, 8, 10,24,48, and 72 hours after-dose at Day 1; 1, 2, 4, 6, 8, 10, and 24 hours after-dose at Cycle 1 Day 28.)
- Clinilca Benefit Rate (CBR)(From date of the first dose until the date of first documented progression or date of death from any cause, assessed up to 100 weeks.)
- Terminal half-life (T1/2)(before administration at Day 1, Cycle1 Day7,Cycle1 Day14, Cycle1 Day28; 1, 2, 4, 6, 8, 10,24,48, and 72 hours after-dose at Day 1; 1, 2, 4, 6, 8, 10, and 24 hours after-dose at Cycle 1 Day 28.)
- Peak concentration (Cmax)(before administration at Day 1, Cycle1 Day7,Cycle1 Day14, Cycle1 Day28; 1, 2, 4, 6, 8, 10,24,48, and 72 hours after-dose at Day 1; 1, 2, 4, 6, 8, 10, and 24 hours after-dose at Cycle 1 Day 28.)
- Objective Response Rate (ORR)(From date of the first dose until the date of first documented progression or date of death from any cause, assessed up to 100 weeks.)
研究者
研究点 (1)
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