A Phase 2, Open-label Study Evaluating STRO-002, an Anti-folate Receptor Alpha (FOLR1) Antibody-Drug Conjugate, in Subjects With Previously Treated Advanced or Metastatic Non-small Cell Lung Cancer Expressing FOLR1
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 入组人数
- 43
- 试验地点
- 7
- 主要终点
- Objective Response Rate (ORR)
研究概览
简要总结
A Phase 2 study evaluating STRO-002 in subjects with previously treated advanced or metastatic non-small cell lung cancer expressing FOLR1
详细描述
This is a multicenter, open-label study. The study is designed to assess the preliminary efficacy and safety of luveltamab tazevibulin, an anti-FOLR1 antibody drug conjugate (ADC) in previously treated subjects with advanced or metastatic NSCLC that expresses FOLR1.
Subjects will receive luveltamab tazevibulin administered intravenously every 3 weeks until disease progression, intolerable toxicity, elective withdrawal from the study, or study termination.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed non-squamous/adenocarcinoma or adenosquamous NSCLC that is either unresectable Stage IIIb/c disease not amenable for definitive chemoradiation, or Stage IV.
- •Age ≥ 18 years
- •ECOG performance status 0 to
- •Received at least 2 but no more than 4 prior lines of systemic therapy for advanced NSCLC
- •Disease progression during or following the most recent systemic anti-cancer therapy.
- •Positive FOLR1 expression per central testing
- •At least 1 measurable target lesion per RECIST 1.1
- •Adequate organ function
排除标准
- •Prior treatment with a FOLR1- targeting ADCs or with ADCs that contain a tubulin inhibitor
- •Untreated central nervous system metastases
- •Ongoing immunosuppressive therapy, except for treated brain metastases, per criterion above.
- •History of severe allergic or anaphylactic reactions to monoclonal antibody therapy or to antibody-related fusion protein treatment
- •Pre-existing clinically significant ocular disorders, severe chronic obstructive pulmonary disease or asthma, clinically significant cardiac or cerebrovascular disease, or other significant concurrent, uncontrolled medical condition
- •Previous solid organ transplantation
- •Concurrent participation in another therapeutic treatment trial
研究组 & 干预措施
Luveltamab tazevibulin
4.3 mg/kg q3w
Eligible subjects with stable disease (SD) may escalate to 5.2 mg/kg q3w after Cycle 4, with Sponsor approval.
干预措施: Luveltamab tazevibulin (Drug)
结局指标
主要结局
Objective Response Rate (ORR)
时间窗: up to 24 months
Best response of complete response (CR) or partial response (PR) per RECIST 1.1
次要结局
- Duration of Response (DOR) per Investigator's assessment.(up to 24 months)
- Progression Free Survival (PFS) by RECIST v1.1 per Investigator's assessment.(up to 24 months)
- Incidence and severity of adverse events and clinical laboratory abnormalities(up to 24 months)
- ADC concentration(up to 24 months)
- Cytotoxic warhead concentration(up to 24 months)
- Total antibody concentration(up to 24 months)