NL-OMON50671已完成不适用
An open-label, first-in-human, multi-center study to evaluate the safety, tolerability, pharmacokinetics and anti-tumor activity of a thorium-227 labeled antibody-chelator conjugate, BAY 2287411 Injection, in patients with solid tumors known to express mesothelin - MSLN-TTC
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 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
- •Inclusion Criteria:
- •- Signed informed consent
- •- Male or female subjects >= 18 years of age
- •- ECOG (Eastern Cooperative Oncology Group) PS of 0 or 1
- •- Patients with advanced malignant epithelioid mesothelioma or advanced
- •recurrent serous ovarian cancer, who have exhausted available therapeutic
- •options; in addition, in the dose expansion part of the study, patients with
- •metastatic pancreatic adenocarcinoma, who have exhausted available therapeutic
- •- Availability of fresh or archival tumor samples
- •- Adequate bone marrow, liver, and renal function, as assessed by the following
- •laboratory requirements (within 28 days before start of study drug treatment)
- •- Negative serum pregnancy test in women of childbearing potential (WOCBP)
- •performed within 7 days before the start of study drug administration. Women
- •and men of reproductive potential must agree to use highly effective methods of
- •contraception, when sexually active.
排除标准
- •Exclusion Criteria:
- •- Impaired cardiac function or clinically significant cardiac disease
- •- Pericarditis (any CTCAE grade) or pericardial effusion (CTCAE Grade >= 2)
- •- Left Ventricular Ejection Fraction (LVEF) < 50% (as measured at screening by
- •echocardiogram).
- •- History of anaphylactic reactions to monoclonal antibody therapy
- •- History of Myelodysplastic syndrome (MDS)/treatment-related acute myeloid
- •leukemia (t-AML) or with features suggestive of MDS/AML
- •- Infections of CTCAE (Common Terminology Criteria for Adverse Events) version
- •5.0 Grade 2 not responding to therapy or active clinically serious infections
- •of CTCAE Grade >2; known human immunodeficiency virus (HIV) infection; active
- •hepatitis B virus (HBV) or hepatitis C virus (HCV)infection requiring
- •treatment. Patients with chronic HBV or HCV infection are eligible at the
- •investigator*s discretion provided that the disease is stable and sufficiently
- •controlled under treatment
- •- Known brain, spinal or meningeal metastases
研究者
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