NCT04993430进行中（未招募）1 期
A Phase 1, Single Arm, Open-Label, Multicenter Study to Evaluate the Safety, Tolerability and Pharmacokinetic of HRS8807 Monotherapy and in Combination With SHR6390 in Subjects With ER-Positive, HER2-Negative Metastatic or Locally Advanced Breast Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- MTD
研究概览
简要总结
The study is to assess safety and tolerability of HRS8807 monotherapy and in combination with SHR6390 in subjects with metastatic or locally advanced breast cancer in order to estimate the Dose-Limiting Toxicity (DLT), Maximum Tolerated Dose (MTD) and select the Recommended Phase 2 Dose (RP2D).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Histological diagnosis of metastatic or locally advanced breast cancer; Histologically proven diagnosis of ER-positive, HER2-negative;
- •At least 1 line of endocrine therapy in the metastatic or advanced setting that had progressed or intolerance; ≤ 2 lines of chemotherapy for metastatic or advanced disease;
- •Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1;
- •Expected survival of more than 3 months.
排除标准
- •All patients in monotherapy and or in combination wih phase who are known allergic to HRS8807 or SHR6390 ingredient;
- •Presence of symptomatic metastatic visceral disease ;
- •Patients with known active brain metastases;
- •Clinically serious cardiovascular disease;
- •Abnormal electrocardiographic (ECG) with clinical significancy by investigator judgement;
- •Abnormal thyroid function laboratory results;
- •Active infection or unexplained fever >38.5℃ during screening period or on the day of the first dose.
研究组 & 干预措施
Group C
Experimental
HRS8807 in combination with SHR6390 dose escalation
干预措施: HRS8807、SHR6390 (Device)
Group A
Experimental
HRS8807 monotherapy dose escalation
干预措施: HRS8807 (Drug)
Group D
Experimental
HRS8807 in combination with SHR6390 dose expansion
干预措施: HRS8807、SHR6390 (Drug)
Group B
Experimental
HRS8807 monotherapy dose expansion
干预措施: HRS8807 (Drug)
结局指标
主要结局
MTD
时间窗: Change From Baseline at 28 days
Maximum Tolerated Dose (MTD) of HRS8807 monotherapy and in combination with SHR6390
Adverse events (AE) and serious AE (SAE)
时间窗: Up to 30 days after end of treatment
AEs and SAEs as characterized by frequency and severity (as graded by National Cancer Institute Common Terminology Criteria for Adverse Events \[NCI CTCAE version 5.0\]).
RP2D
时间窗: Change From Baseline at 28 days
select the Recommended Phase 2 Dose (RP2D) of HRS8807 monotherapy and in combination with SHR6390
次要结局
- AUC0-∞ of HRS8807 and the major metabolite after single dose of HRS8807(Day 1, Day 2, Day 3 of single dose (3 days before Cycle1))
- Vz/F of HRS8807 and the major metabolite after single dose of HRS8807(Day 1, Day 2, Day 3 of single dose (3 days before Cycle1))
- Cmax,ss of HRS8807, the major metabolite and SHR6390 after multiple dose administration of HRS8807 and SHR6390(Cycle 1 Day 14, Day 15, each cycle is 28 days)
- Tmax,ss of HRS8807 and the major metabolite after multiple dose administration of HRS8807(Cycle 1 Day 14, Day 15, each cycle is 28 days)
- Cmax,ss of HRS8807 and the major metabolite after multiple dose administration of HRS8807(Cycle 1 Day 14, Day 15, each cycle is 28 days)
- Rac of HRS8807 and the major metabolite after multiple dose administration of HRS8807(Cycle 1 Day 14, Day 15, each cycle is 28 days)
- Rac of HRS8807, the major metabolite and SHR6390 after multiple dose administration of HRS8807 and SHR6390(Cycle 1 Day 14, Day 15, each cycle is 28 days)
- Tmax of HRS8807 and the major metabolite after single dose of HRS8807(Day 1, Day 2, Day 3 of single dose (3 days before Cycle1))
- Cmax of HRS8807 and the major metabolite after single dose of HRS8807(Day 1, Day 2, Day 3 of single dose (3 days before Cycle1))
- AUC0-t of HRS8807 and the major metabolite after single dose of HRS8807(Day 1, Day 2, Day 3 of single dose (3 days before Cycle1))
- t1/2 of HRS8807 and the major metabolite after single dose of HRS8807(Day 1, Day 2, Day 3 of single dose (3 days before Cycle1))
- Cmin,ss of HRS8807 and the major metabolite after multiple dose administration of HRS8807(Cycle 1 Day 14, Day 15, each cycle is 28 days)
- AUCss of HRS8807 and the major metabolite after multiple dose administration of HRS8807(Cycle 1 Day 14, Day 15, each cycle is 28 days)
- Tmax of HRS8807, the major metabolite and SHR6390 after single dose administration of HRS8807 and SHR6390(Cycle 1 Day 1, Day 2, each cycle is 28 days)
- Cmax of HRS8807, the major metabolite and SHR6390 after single dose administration of HRS8807 and SHR6390(Cycle 1 Day 1, Day 2, each cycle is 28 days)
- AUC0-t of HRS8807, the major metabolite and SHR6390 after single dose administration of HRS8807 and SHR6390(Cycle 1 Day 1, Day 2, each cycle is 28 days)
- Tmax,ss of HRS8807, the major metabolite and SHR6390 after multiple dose administration of HRS8807 and SHR6390(Cycle 1 Day 14, Day 15, each cycle is 28 days)
- Cmin,ss of HRS8807, the major metabolite and SHR6390 after multiple dose administration of HRS8807 and SHR6390(Cycle 1 Day 14, Day 15, each cycle is 28 days)
- AUCss of HRS8807, the major metabolite and SHR6390 after multiple dose administration of HRS8807 and SHR6390(Cycle 1 Day 14, Day 15, each cycle is 28 days)
- Objective Response Rate (ORR)(baseline to the date of first documentation of progression, assessed approximately up to 6 months after the last entered participant)
- Duration of Response (DoR)(baseline to the date of first documentation of progression, assessed approximately up to 6 months after the last entered participant)
- Progression Free Survival (PFS)(baseline to the date of first documentation of progression, assessed approximately up to 6 months after the last entered participant)
- CL/F of HRS8807 and the major metabolite after single dose of HRS8807(Day 1, Day 2, Day 3 of single dose (3 days before Cycle1))
研究者
研究点 (1)
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