A Phase 1a/1b Dose Escalation and Expansion Study of Single-agent SC-002 in Subjects With Relapsed or Refractory Small Cell Lung Cancer and Large Cell Neuroendocrine Carcinoma
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 35
- 主要终点
- Number of subjects with adverse events as a measure of safety and tolerability
研究概览
简要总结
This is a Phase 1a/1b study of SC-002 in patients with relapsed small cell lung cancer (SCLC) or large cell neuroendocrine carcinoma (LCNEC). SC-002 is an antibody-drug conjugate (ADC) comprised of a monoclonal antibody linked to a potent chemotherapy.
The purpose of this study is to assess the safety and tolerability of SC-002 at different dose levels, to determine the highest dose of SC-002 that can be given to patients with SCLC or LCNEC, to evaluate the side effects of SC-002, and to assess the anti-cancer activity of SC-002.
详细描述
Part 1A is a dose escalation study in patients with small cell lung cancer or large cell neuroendocrine carcinoma with cytologically confirmed, limited or extensive SCLC or LCNEC that have relapsed or refractory limited or extensive disease following no more than 2 prior chemotherapy regimens.
Part 1B is an expansion study where patients will be enrolled and treated in order to further characterize safety and preliminary efficacy in patients with SCLC or LCNEC and further characterize PK, immunogenicity and target expression and possible relationship to clinical outcome.
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 SCLC (either limited or extensive disease) or LCNEC, that has relapsed from the most current treatment or was refractory to treatment
- •Evidence of progressive disease during or following no more than 2 prior chemotherapy regimens
- •Measurable disease as defined by RECIST
- •ECOG performance status of 0 or 1
- •Adequate hematological and organ function as confirmed by laboratory values
- •Treatment with anticancer/investigational drugs, therapy ≤ 4 weeks prior to first dose of SC-002
排除标准
- •Active central nervous system metastases
- •Uncontrolled cardiac disease
- •Positive serology for hepatitis B or hepatitis C or known HIV infection
- •Presence of any condition that may increase the risks associated with study participation and interfere with the interpretation of study results
研究组 & 干预措施
SC-002
Part 1A (Dose Escalation) - IV infusion; safety data will be reviewed prior to dose escalation decision. Dose escalation will complete when recommended dose (RD) is determined. RD will be the maximum tolerated dose (MTD) or lower dose that provides adequate PK exposure, immunogenicity, and preliminary evidence of antitumor activity with tolerability.
Part 1B (Dose Expansion) - IV infusion; once MTD and/or RD has been determined in Part 1A, an expansion cohort of approximately 60 patients with SCLC or LCNEC will be enrolled to further characterize the safety profile and clinical activity of the RD. Patients may continue treatment until disease progression, unacceptable toxicity, or withdrawal of consent.
干预措施: SC-002 (Drug)
结局指标
主要结局
Number of subjects with adverse events as a measure of safety and tolerability
时间窗: 6 months
Maximum tolerated dose
时间窗: 6 months
次要结局
- Pharmacokinetics of SC-002(Cycle 1 and 4: days 1, 2, 4, 8, 15; Cycles 2, 3, and 5: day 1 only)
- RECIST v1.1 assessed objective response rate(6 months)