jRCT2031220511已完成不适用
An Open-Label, Multicenter Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Anti-Tumor Activity of RO7616789 in Participants With Advanced Small Cell Lung Cancer and Other Neuroendocrine Carcinomas
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 168
- 主要终点
- Safety
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Single Arm Study
- 干预模型
- Single Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •Life expectancy at least 12 weeks
- •Eastern Cooperative Oncology Group(ECOG) performance status of 0 or 1
- •Adequate hematologic and end organ function
- •Negative serum pregnancy test.
- •Adequate contraception and no or interruption of breastfeeding
- •Histologically confirmed extensive SCLC or high grade NEC of any other origin that have relapsed after at least 1 systemic therapy and for which standard therapy has proven to be i-neffective or intolerable or is considered inappropriate.
- •Measurable disease according to Response Evaluation criteria in Solid Tumors (RECIST) Version 1.1
- •Confirmed availability of representative archival tumor specimens in formalin-fixed, paraffin-embedded (FFPE) blocks or unstained slides
排除标准
- •History or clinical evidence of primary central nervous system (CNS) malignancy, symptomatic CNS metastases, CNS metastases requiring any anti-tumor treatment, or leptomeningeal disease and current or history of CNS disease, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease
- •Active or history of clinically significant autoimmune disease
- •Positive test for human immunodeficiency virus (HIV) infection
- •Active hepatitis B or hepatitis C
- •Prior treatment with anti-cluster of differentiation (CD)137 agents, anti-CD3 agents and/or delta-like ligand 3 (DLL3) targeted therapies
- •Any anti-cancer therapy, whether investigational or approved, including chemotherapy, hormonal therapy, or radiotherapy, within 21 days prior to initiation of study treatment
- •Any history of an immune-related Grade 4 adverse event (AE) attributed to prior anti-programmed death ligand-1 (PD-L1) /PD-1 or anti-cytotoxic T-lymphocyte-associated protein (CTLA-4) therapy (other than asymptomatic elevation of serum amylase or lipase)
- •Any history of an immune-related Grade 3 adverse event attributed to prior anti-PD-L1 /PD-1 or anti-CTLA-4 therapy (other than asymptomatic elevation of serum amylase or lipase) that resulted in permanent discontinuation of the prior immunotherapeutic agent
- •Administration of a live, attenuated vaccine within 4 weeks before first RO7616789 infusion
结局指标
主要结局
Safety
Evaluation of safety and tolerability based on NCI CTCAE
Efficacy
Efficacy evaluation based on RECIST
次要结局
- Efficacy
- Phamacokinetics
研究者
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