NCT06612151进行中（未招募）3 期
A Multicenter, Randomized, Controlled, Open-label, Phase III Study to Compare the Efficacy and Safety of YL201 Versus Topotecan Hydrochloride in Subjects With Relapsed Small Cell Lung Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 438
- 试验地点
- 1
- 主要终点
- To compare the OS of YL201 versus topotecan hydrochloride in subjects with relapsed SCLC.
研究概览
简要总结
This study was designed to compare the efficacy and safety of YL201 with Topotecan Hydrochloride in subjects with relapsed small cell lung cancer (SCLC).
详细描述
The primary objective of this study is to assess whether treatment with YL201 prolongs overall survival (OS) compared with treatment of topotecan hydrochloride among subjects with relapsed SCLC.
The secondary objectives of the study are to further evaluate the efficacy, safety, pharmacokinetics, and immunogenicity of YL201, and the correlation between B7-H3 expression level and the efficacy of YL201.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- All
- 接受健康志愿者
- 否
入选标准
- •Sign and date the informed consent form prior to the start of any study-specific qualification procedures.
- •Aged ≥18 and ≤75 years, male or female.
- •ECOG PS 0 or
- •Life expectancy ≥ 3 months.
- •Histologically or cytologically confirmed SCLC. Subjects with combined SCLC or any transformed SCLC are not eligible.
- •Has limited-stage or extensive-stage disease at study entry, with progression on or after first-line platinum-based therapy (at least 2 cycles).
- •At least one measurable lesion according to RECIST version 1.
- •Subjects are willing to provide tumor tissue (freshly obtained or archived) for detection of B7-H3 expression.
- •Adequate organ function.
排除标准
- •History of other malignant tumors within 5 years prior to the first dose of study drug. Subjects cured by radical treatment are not included, such as basal cell carcinoma, squamous cell carcinoma of skin, superficial bladder cancer, carcinoma in situ of the cervix, or breast cancer in situ.
- •Previously received B7-H3-targeted therapy, including antibody, antibody-drug conjugate (ADC), and chimeric antigen receptor T cell (CAR-T).
- •Previously received treatment with a topoisomerase I inhibitor or an ADC consisting of a topoisomerase I inhibitor.
- •Inadequate washout period for prior anti-tumor treatment before the first dose of study drug.
- •Received systemic steroids or other immunosuppressive therapy within 2 weeks before the first dose of study drug.
- •Received any live vaccine within 4 weeks before the first dose of study drug or intend to receive a live vaccine during the study.
- •Presence of brain stem or meningeal metastases, spinal cord metastases or compression.
- •Presence of central nervous system (CNS) metastasis. Participants with treated brain metastases are eligible if the metastases are asymptomatic and stable, and no immediate local or systemic treatment is needed within 2 weeks before the first dose.
- •Presence of pleural effusion, pericardial effusion, or ascites with clinical symptoms or requiring repeated drainage.
- •Has an uncontrolled concurrent disease.
- •Presence of severe uncontrolled cardiovascular disorder.
- •History of interstitial lung disease (ILD) or pneumonitis that required corticosteroids, or current ILD/pneumonitis
- •Concomitant pulmonary disorder leading to clinically severe respiratory impairment.
- •Chronic autoimmune or inflammatory diseases requiring or receiving systemic therapy within 2 years prior to the first dose.
- •Serious infections within 4 weeks prior to the first dose.
- •Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
- •Unresolved toxicities from previous antitumor therapy.
- •Known hypersensitivity to any component of any study drug; history of severe allergy or known history of serious hypersensitivity to other monoclonal antibodies or recombinant protein products, or history of severe infusion reactions.
- •Pregnancy, breastfeeding, or women planning to become pregnant or breastfeed during the study.
- •Any illness, medical condition, organ system dysfunction, or social situation deemed by the investigator to be likely to interfere with a subject's ability to sign informed consent, adversely affect the subject's ability to cooperate and participate in the study, or compromise the interpretation of study results.
研究组 & 干预措施
topotecan hydrochloride for injection
Active Comparator
Participants are randomized to receive topotecan hydrochloride intravenously, on Days 1 to 5 of each 3-week cycle per prescribing information, until PD, unacceptable toxicity, or withdrawal of consent as specified in the protocol.
干预措施: topotecan hydrochloride for injection (Drug)
YL201
Experimental
Participants are randomized to receive YL201 monotherapy intravenously on Day 1 of each 3-week cycle at RP3D dose level, until progressive disease (PD), unacceptable toxicity, or withdrawal of consent as specified in the protocol.
干预措施: YL201 (Drug)
结局指标
主要结局
To compare the OS of YL201 versus topotecan hydrochloride in subjects with relapsed SCLC.
时间窗: Approximately within 36 months
(OS) defined as the time interval from the first randomization to death due to any cause.
次要结局
- To compare Investigator-assessed progression-free survival (PFS) of YL201 versus topotecan hydrochloride in subjects with relapsed SCLC.(Approximately within 36 months)
- To compare Investigator-assessed objective response rate (ORR) of YL201 versus topotecan hydrochloride in subjects with relapsed SCLC.(Approximately within 36 months)
- To compare duration of response (DoR) as assessed by the investigator of YL201 versus topotecan hydrochloride in subjects with relapsed SCLC.(Approximately within 36 months)
- To compare time to response (TTR) as assessed by the investigator of YL201 versus topotecan hydrochloride in subjects with relapsed SCLC.(Approximately within 36 months)
- To compare disease control rate (DCR) assessed by the investigator of YL201 versus topotecan hydrochloride in subjects with relapsed SCLC.(Approximately within 36 months)
- To evaluate the incidence and severity of adverse events (AEs) of YL201.(Approximately within 36 months)
- To evaluate the concentration-time data for YL201, total antibody, and payload(Approximately within 36 months)
- To characterize the PK parameter AUC(Approximately within 36 months)
- Characterize the PK parameter Cmax(Approximately within 36 months)
- To characterize the PK parameter Ctrough(Approximately within 36 months)
- To characterize the PK parameter CL(approximately within 36 months)
- Characterize the PK parameter Vd(approximately within 36 months)
- Characterize the PK parameter t1/2(Approximately within 36 months)
- Assessment of B7H3 expression level in tumor tissue and the correlation between the expression level and the efficacy of YL201.(Approximately within 36 months)
- Assessment of the number of subjects who are Anti-Drug Antibody (ADA)-positive at any time and who have a treatment-emergent ADA(Approximately within 36 months)
研究者
研究点 (1)
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