EUCTR2021-000857-23-DK进行中（未招募）1 期
A Phase I/II, Open-label, Dose Escalation and Dose Expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of AZD2936 Anti TIGIT/Anti-PD-1 Bispecific Antibody in Participants with Advanced or Metastatic Non small Cell Lung Cancer (ARTEMIDE-01) - ARTEMIDE-01
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 192
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Written informed consent
- •- Aged 18 or above
- •- Part A and Part B: Unresectable stage III or stage IV squamous or non
- •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.
- •- Confirmed progression during treatment with a CPI-including regimen
- •(Part A, Part B).
- •- No prior IO treatment for metastatic NSCLC (Part C, Part D).
- •- ECOG performance status of 0 or 1 at enrolment.
- •- Life expectancy of = 12 weeks at enrolment.
- •- Have at least 1 measurable lesion per RECIST v1.1
- •- Adequate bone marrow, liver and kidney function.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 96
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 96
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 and Part B: Primary or secondary resistance after treatment with 2 or more regimens 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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