NCT06439771招募中2 期
A Multicenter, Open-Label, Phase 2 Study to Evaluate the Efficacy, Safety and Pharmacokinetics of YL202 in Patients With Locally Advanced or Metastatic Breast Cancer With TNBC, HR-Positive, HER2-Zero-expression or HER2-Low-expression
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Determination of the recommended dose of YL202 in the pivotal clinical study
研究概览
简要总结
This study is a multicenter, open-label, phase 2 clinical study to evaluate the efficacy, safety and pharmacokinetics of YL202 in patients with locally advanced or metastatic breast cancer with TNBC, HR-positive, HER2-zero-expression or HER2-low-expression
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
- •Have been informed of the study before the start of the study and voluntarily sign name and date on the informed consent form.
- •Patients with locally advanced or metastatic disease (according to the UICC and AJCC staging system [Version 8]) who are not candidates for curative surgery or radiotherapy.
- •Patients who are pathologically confirmed advanced/unresectable or metastatic breast cancer with HR-negative and HER2-negative,.
- •Patients who are confirmed HR positive and HER2-Zero-expression and HER2-Low-expression.
- •Breast cancer patients who have previously failed treatments of HER2-ADC or TROP2-ADC.
- •Have at least 1 extracranial measurable lesion as a target lesion per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
- •Have Adequate organ and bone marrow function within 7 days prior to the first dose.
- •Female patients of childbearing potential must agree to use highly effective contraception from screening throughout the duration of the study and for at least 6 months after the last dose of study drug.
- •Have a expected survival ≥ 3 months.
- •Have ability and willingness to comply with protocol-specified visits and procedures.
排除标准
- •Have prior treatment with an agent targeting HER
- •Have prior intolerance to treatment with topoisomerase I inhibitor or an ADC that consists of topoisomerase I inhibitor.
- •Have been enrolled in another clinical study concurrently unless it is an observational clinical study or in the follow-up phase of an interventional study.
- •Have insufficient washout period for prior anticancer therapy prior to first dose of the study drug.
- •Have major surgery (excluding diagnostic surgery) within 4 weeks prior to the first dose of study drug or anticipation of major surgery during the study.
- •Have prior allogeneic bone marrow transplant or prior solid organ transplant.
- •Have received treatment with systemic steroids.
- •Have received any live vaccine within 4 weeks prior to the first dose of study drug or intend to receive a live vaccine during the study.
- •Leptomeningeal metastases or carcinomatous meningitis, spinal cord compression.
- •Brain metastases with the exceptions.
- •Have uncontrolled or clinically significant cardiovascular and cerebrovascular disease.
- •Have clinically significant concomitant pulmonary diseases.
- •Have a diagnosis of Gilbert's syndrome.
- •Have pleural effusion, abdominal effusion.
- •Have a history of gastrointestinal perforation and or fistula within 6 months prior to the first dose.
- •Have serious infection.
- •Patients with human immunodeficiency virus (HIV) infection.
- •Have active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
- •Have any other primary malignancy within 5 years prior to the first dose of study drug.
- •Have unresolved toxicities from prior anticancer therapy.
- •Have a history of severe hypersensitivity reactions to the drug substance, inactive ingredients in the drug product, or other monoclonal antibodies.
- •Lactating women, or women who are confirmed to be pregnant by pregnancy test within 3 days prior to the first dose.
研究组 & 干预措施
Experimental: Corhort B
Experimental
YL202 is provided as the lyophilized powder, 200 mg/vial. HR-positive breast cancer with HER2-Zero-expression and HER2-Low-expression patients will be given YL202 by intravenously once every 3 weeks (Q3W) as a cycle.
干预措施: YL202 should be intravenously infused (Drug)
Experimental: Corhort A
Experimental
YL202 is provided as the lyophilized powder, 200 mg/vial. Triple-negative breast cancer (TNBC) patients will be given YL202 by intravenously once every 3 weeks (Q3W) as a cycle.
干预措施: YL202 should be intravenously infused (Drug)
Experimental: Corhort C
Experimental
YL202 is provided as the lyophilized powder, 200 mg/vial. Breast cancer patients who have previously failed treatments of HER2-ADC or TROP2-ADC (excluding HER2+ patients, ie, HER2 IHC 3+ or IHC 2+/ISH+ patients) will be given YL202 by intravenously once every 3 weeks (Q3W) as a cycle.
干预措施: YL202 should be intravenously infused (Drug)
结局指标
主要结局
Determination of the recommended dose of YL202 in the pivotal clinical study
时间窗: By the end of trial date, approximately within 36 months
ORR assessed according to RECIST v1.1
时间窗: By the end of trial date, approximately within 36 months
ORR: defined as the proportion of patients who achieved a best overall response of complete response (CR) or partial response (PR).
次要结局
- Progression-free survival (PFS) assessed according to RECIST v1.1(By the end of trial date, approximately within 36 months)
- Clinical benefit rate (CBR) assessed based on RECIST v1.1(By the end of trial date, approximately within 36 months)
- Depth of response (DpR) assessed based on RECIST v1.1(By the end of trial date, approximately within 36 months)
- Duration of response (DOR) assessed based on RECIST v1.1(By the end of trial date, approximately within 36 months)
- Disease control rate (DCR) assessed based on RECIST v1.1(By the end of trial date, approximately within 36 months)
- Time to response (TTR) assessed based on RECIST v1.1(By the end of trial date, approximately within 36 months)
- Evaluate the overall survival (OS)(By the end of trial date, approximately within 36 months)
- Characterize the PK parameter Cmax(Approximately within 36 months)
- Characterize the PK parameter Ctrough(Approximately within 36 months)
- Characterize the PK parameter CL(Approximately within 36 months)
- Characterize the PK parameter Vd(Approximately within 36 months)
- Adverse event (AE), described in terms of type, frequency, severity, time, and relationship with study treatment(Approximately within 36 months)
- Characterize the PK parameter AUC(Approximately within 36 months)
- Characterize the PK parameter t1/2(Approximately within 36 months)
- Incidence of anti-YL202 antibody(Approximately within 36 months)
- Evaluate the corelaton between different levels of HER3 expression and the sum of CR rate, PR rate and SD rate(Approximately within 36 months)
研究者
研究点 (1)
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