JPRN-jRCT2031220297招募中1 期
This is a Phase I/II study designed to evaluate if experimental anti-TIGIT/anti-PD-1 bispecific antibody, AZD2936 is safe, tolerable and efficacious in participants with Advanced or Metastatic Non-small Cell Lung Cancer. - ARTEMIDE-01
Hibi Kazushige0 个研究点目标入组 18 人开始时间: 2022年8月27日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 18
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •Written informed consent
- •- Aged 18 or above
- •- Part A: Unresectable stage III or stage IV squamous or non-squamous NSCLC not amenable to curative surgery or radiation. Part C and Part D: Stage IV squamous or non-squamous NSCLC not amenable to curative surgery or radiation.
- •- Documented PD-L1 expression by PD-L1 IHC per local report.
- •- Part A : Confirmed progression during treatment with a CPI-including regimen.
- •- Part C and Part D: No prior I/O treatment for metastatic NSCLC.
- •- ECOG performance status of 0 or 1 at enrolment.
- •- Life expectancy of 12 weeks or more at enrolment.
- •- Have at least 1 measurable lesion per RECIST v1.1.
- •- Adequate bone marrow, liver and kidney function
排除标准
- •- Sensitizing epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) fusion
- •- Documented test result for any other known genomic alteration for which a targeted therapy is approved in first line per local standard of care (e.g. ROS1, NTRK fusions, BRAF, V600E mutation)
- •- Previous treatment with an anti-TIGIT therapy
- •- Any concurrent chemotherapy, radiotherapy, investigational, biologic, or hormonal therapy for cancer treatment.
- •- Part A : Primary or secondary resistance after treatment with 2 or more regiments including a CPI.
- •- Part C and Part D: Any prior systemic treatment with an immune oncology agent (prior administration of immune-oncology agent for curative intent to treat other invasive malignancy is permitted). Treatment with one previous systemic chemotherapy will be allowed.
- •- Symptomatic central nervous system (CNS) metastasis.
- •- Thromboembolic event within 3 months prior to enrolment.
- •- Other invasive malignancy within 2 years prior to screening.
研究者
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