JPRN-jRCT2031200207已完成1 期
An open label phase Ib dose finding study of BI 836880 in combination with ezabenlimab to characterize safety, tolerability,pharmacokinetics, pharmacodynamics and efficacy in patients with locally advanced or metastatic non-squamous Non-Small Cell Lung Cancer and in other solid tumors
Yamagami Tomohiro0 个研究点目标入组 6 人开始时间: 2020年11月18日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 6
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
- •1.Of full age (according to local legislation, usually >= 18 years) at screening
- •2.At least one measurable target lesion outside the brain (excluding the glioblastoma patients), that can be accurately measured per RECIST v 1.1
- •3.ECOG performance status <= 1 (Karnofsky status for GBM)
- •4.Adequate hepatic, renal and bone marrow functions
- •5.Availability and willingness to provide a fresh tumor tissue sample obtained after relapse or progression on or after prior therapy. In case a fresh biopsy cannot be obtained (e.g. inaccessible lesions or patient safety concern), an archived specimen obtained up to 6 months prior to cycle 1, visit 1 (C1V1) may be submitted in case no systemic antineoplastic therapy has been administered between the biopsy and C1V1 (except for cohort D). For cohorts E, F and G, a fresh on-treatment biopsy is mandatory at C3D1, if possible from the same lesion as the pre-treatment biopsy.
- •6.Life expectancy >= 3 months after start of the treatment in the opinion of the investigator
排除标准
- •1.Not more than one CPI based treatment regimen prior to entering study (eg. anti-Programmed Death receptor-1 (PD-1), anti-Programmed Death-1 ligand-1 (PD-L1), anti-PD-L2, or anti-cytotoxic T lymphocyte associated antigen-4 (anti-CTLA-4) antibody) unless combination CPIs approved by the local regulatory agencies; For eg., Melanoma cohort (Cohort E)
- •2.Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection (exception for patients in HCC cohorts; Cohort F & cohort G).
- •3.Prior treatment with any antiangiogenic treatment (e.g. bevacizumab, cediranib, aflibercept, vandetanib, XL-184, sunitinib, etc) except for sorafenib and lenvatinib in 2nd line HCC cohort (Cohort F).
- •4.Patients with known active second malignancy other than non-melanoma skin cancers, non-metastatic prostate cancer, in situ cervical cancer, and ductal or lobular carcinoma in situ of the breast. Patients are not considered to have a currently active malignancy if they have completed anticancer therapy and have been disease free for greater than 2 years prior to screening
- •Further exclusion criteria:
- •Exclusion criteria for Glioblastoma:
- •5.Tumor primarily localized to the brainstem or spinal cord.
- •6.Presence of diffuse leptomeningeal disease or extracranial disease.
- •7.Is known to have IDH mutant variety of recurrent glioblastoma.
- •8.Any prior treatment with prolifeprospan 20 with carmustine wafer.
- •9.Any prior treatment with an intracerebral agent.
- •Exclusion criteria for Melanoma cohort:
- •10.Uveal or ocular melanoma
- •Exclusion criteria for HCC cohorts (Cohorts F & G):
- •11.Co-infection with HBV and HCV or HBV and hepatitis D virus (HDV)
- •12. Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC
- •13.History of hepatic encephalopathy
- •14.Untreated or incompletely treated varices with bleeding or high-risk for bleeding
- •15. Untreated active Hepatitis B virus (HBV)
- •16. Treatment with any HCV anti-viral therapy within 4 weeks prior to Cycle 1 Day 1
研究者
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