EMERGE-201: A Phase 2, Multicenter, Open-label Study of Lurbinectedin Efficacy and Safety in Participants With Advanced or Metastatic Solid Tumors
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 47
- 试验地点
- 17
- 主要终点
- Investigator-Assessed Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1
研究概览
简要总结
This is an open-label, multicenter, phase 2 study of lurbinectedin monotherapy in participants with advanced (metastatic and/or unresectable) solid tumors.
详细描述
This phase 2, multicenter, open-label study is designed to assess the safety and efficacy of lurbinectedin monotherapy in 3 cohorts of participants with high-unmet medical need: advanced (metastatic and/or unresectable) urothelial cancer (UC), poorly differentiated neuroendocrine carcinomas (PD-NEC), and a homologous recombination deficient-positive malignancies agnostic cohort.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent
- •≥ 18 years of age
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •Adequate organ and bone marrow function
- •Has measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.
- •Have advanced (metastatic/unresectable) cancers in one of the following:
- •Histologically or cytologically confirmed urothelial cancer
- •Histologically or cytologically confirmed poorly differentiated neuroendocrine carcinoma
- •Histologically or cytologically confirmed homologous recombination deficient-positive malignancies agnostic, which may include endometrial, biliary tract, urothelial, breast (TNBC or HR+HER2- breast cancer), pancreas, gastric, or esophageal solid tumors with preidentified germline and/or somatic pathogenic mutation
- •Adequate contraceptive precautions
排除标准
- •Known symptomatic central nervous system (CNS) metastasis requiring steroids
- •History of prior malignancy within 2 years of enrollment
- •Clinically significant cardiovascular disease
- •Active infection requiring systemic therapy
- •Significant non-neoplastic liver disease
- •Prior treatment with trabectedin or lurbinectedin
- •Treatment with an investigational agent within 4 weeks of enrollment
- •Received live vaccine with 4 weeks of first dose
- •Prior allogeneic bone marrow or solid organ transplant
- •Positive hepatitis B virus (HBV) or hepatitis C virus (HCV) infection at screening
- •Positive human immunodeficiency virus (HIV) infection at screening
研究组 & 干预措施
Urothelial Cancer Cohort
Participants with advanced (metastatic and/or unresectable) urothelial carcinoma who have progressed on platinum-containing regimen (prior therapies may include but are not limited to immune checkpoint inhibitor, enformumab vendotin, or sacituzumab govitecan) will receive Lurbinectedin 3.2 mg/m^2 intravenous (IV) on Day 1 of every 3 weeks (Q3W) cycle until confirmed disease progression, withdrawal of participant consent, participant lost to follow-up, unacceptable toxicity, or the study or individual cohort may be terminated by the sponsor for lack of efficacy signal or any other reason.
干预措施: Lurbinectedin (Drug)
Poorly Differentiated Neuroendocrine Carcinomas Cohort
Participants with advanced (metastatic and/or unresectable) poorly differentiated neuroendocrine carcinomas who received at least 1 prior line of therapy will receive Lurbinectedin 3.2 mg/m^2 intravenous (IV) on Day 1 of every 3 weeks (Q3W) cycle until confirmed disease progression, withdrawal of participant consent, participant lost to follow-up, unacceptable toxicity, or the study or individual cohort may be terminated by the sponsor for lack of efficacy signal or any other reason.
干预措施: Lurbinectedin (Drug)
Homologous Recombination Deficient-Positive Malignancies Agnostic Cohort
Participants with advanced (metastatic and/or unresectable) endometrial, biliary tract, urothelial, breast (TNBC or HR+HER2- breast cancer), pancreas, gastric, or esophageal solid tumors with preidentified germline and/or somatic pathogenic mutation and received at least 1 prior line of therapy will receive Lurbinectedin 3.2 mg/m^2 intravenous (IV) on Day 1 of every 3 weeks (Q3W) cycle until confirmed disease progression, withdrawal of participant consent, participant lost to follow-up, unacceptable toxicity, or the study or individual cohort may be terminated by the sponsor for lack of efficacy signal or any other reason.
干预措施: Lurbinectedin (Drug)
结局指标
主要结局
Investigator-Assessed Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1
时间窗: Baseline to disease progression or death, up to 36 weeks.
The ORR is defined as the proportion of participants whose best overall response (BOR) is investigator-assessed confirmed complete response (CR) or partial response (PR) using the RECIST v1.1 criteria. BOR is defined as the best response recorded between the date of first dose and the date of objectively documented progression per RECIST v1.1, or the date of subsequent anticancer therapy, death due to any cause, loss to follow-up, or study discontinuation, whichever occurs first.
次要结局
- Investigator-Assessed Progression Free Survival (PFS) as Assessed Per Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1(Baseline to disease progression or death, up to 36 weeks)
- Investigator-Assessed Time-To-Response (TTR) as Assessed Per Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1(Baseline to disease progression or death, up to 36 weeks)
- Investigator-Assessed Duration of Response (DOR) as Assessed Per Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1(Baseline to disease progression or death, up to 36 weeks)
- Investigator-assessed Disease Control Rate (DCR) as Assessed Per Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1(Baseline to disease progression or death, up to 36 weeks.)
- Overall Survival (OS) in Participants Treated With Lurbinectedin(Baseline and every 3 months, up to 16 months)