NL-OMON54261招募中2 期
A Phase I/II, Open-label, Dose Escalation and Dose Expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of rilvegostomig (AZD2936) Anti-TIGIT/Anti-PD-1 Bispecific Antibody in Participants with Advanced or Metastatic Non-small Cell Lung Cancer (ARTEMIDE-01) - ARTEMIDE-01
Astra Zeneca0 个研究点目标入组 18 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 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
- 18 至 99（—）
入选标准
- •Disease for part D only:
- •Stage IV squamous or non-squamous NSCLC.
- •PD-L1 TPS >= 50%
- •provision of archival tumor tissue (or fresh tumor tissue biopsy must
- •be confirmed if archival tumor tissue is not available and if clinically
- •feasible) is mandatory at screening for all study parts
- •No sensitizing EGFR mutations or ALK fusions.
- •No documented test result for other known genomic alteration for which a
- •targeted therapy is approved in first line per local standard of care (ROS1,
- •NTRK fusions, BRAF, V600E mutation, etc.)
- •Prior therapy:
- •Part D (Dose Expansion): Must meet one of the definitions below:
- •(i) No prior treatment for NSCLC, and not in need of rapid disease control via
- •chemotherapy-containing regimen, or
- •(ii) Prior treatment for NSCLC with one regimen consisting of chemotherapy only.
- •No unresolved toxicities of >= Grade 2 (CTCAE v5.0) from prior therapy
- •vitiligo, alopecia, endocrine disorders that are controlled with replacement
- •therapy, asymptomatic laboratory abnormalities).
- •Overall condition:
- •ECOG performance status 0 or 1 at enrolment.
- •Life expectancy of >= 12 weeks at enrolment.
- •Adequate bone marrow, liver and kidney function.
排除标准
- •- Participants with either of the following are excluded:
- •(a) Sensitizing epidermal growth factor receptor mutations or anaplastic
- •lymphoma kinase fusions (documented test result is mandatory for patients with
- •non-squamous histology). For patients with squamous histology mutation, testing
- •is mandatory only
- •if participant is a never smoker or in the presence of a mixed histology.
- •(b) Documented test result for any other known genomic alteration for which a
- •targeted therapy is approved in first line per local standard of care (eg,
- •ROS1, NTRK fusions, BRAF, V600E mutation, etc).
- •- part D only:
- •Any prior systemic treatment with an immune-oncology agent, including but
- •not limited to anti-PD-1, anti-PD-L1, anti-CTLA-4. Treatment with one previous
- •systemic chemotherapy will be allowed.
- •- Symptomatic central nervous system (CNS) metastasis.
- •(a) Note: Participants with known CNS lesions should be asymptomatic,
- •adequately treated with stereotactic radiation therapy, craniotomy, gamma knife
- •therapy, or whole brain radiotherapy, with no subsequent evidence of CNS
- •progression (documented with magnetic resonance imaging [MRI] scans showing the
- •absence of brain metastasis progression after radiotherapeutic intervention);
- •participants must not require steroid exceeding 10 mg prednisone or 2 mg/day of
- •dexamethasone or equivalent; participants with a history of CNS metastases must
- •have MRI of the brain at screening. Participants with CNS metastases who are
- •receiving steroids must be on a stable dose of steroids for >= 7 days prior to
- •study entry and prior to baseline imaging.
- •- Thromboembolic event within 3 months before the first dose of investigational
- •- History of organ transplant.
- •- Active primary immunodeficiency/active infectious disease(s):
- •(a) Active infection including tuberculosis (TB) (clinical evaluation that
- •includes clinical history, physical examination, and radiographic findings and
- •TB testing in line with local practice).
- •(b) Human immunodeficiency virus (HIV) (positive for HIV-1 or HIV-2 antibodies).
- •(c) Chronic or active hepatitis B, chronic or active hepatitis C; however,
- •participants who have chronic hepatitis B and are receiving suppressive
- •antiviral therapy are allowed to be enrolled if alanine aminotransferase (ALT)
- •is normal and viral load is controlled. Controlled hepatitis B viral load is
- •defined as serum hepatitis B virus DNA < 100 U/mL by polymerase chain reaction
- •(PCR). Participants with controlled hepatitis B viral load must remain on
- •antiviral therapy, per institutional practice, during the study treatment and
- •follow-up period to ensure adequate viral suppression. Participants who have
- •chronic hepatitis C are allowed to be enrolled if ALT is normal and hepatitis C
- •virus (HCV) RNA undetectable by PCR, either spontaneously or in response to a
- •successful prior course of anti-hepatitis C therapy (Regev et al,
- •2020).Controlled hepatitis C viral load is defined as undetectable hepatitis C
- •either spontaneously or in response to a successful prior course of
- •anti-hepatitis C therapy.
- •(d) Acute hepatitis A.
- •(e) For all participants in the study, all local institutional standards for
- •coronavirus disease 2019 (COVID-19) must be followed for testing. For
- •participants with a known previous COVID-19 infection, either
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