jRCT2031200207已完成不适用
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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 6
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Single Arm Study
- 干预模型
- Single Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 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)
- •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
- •Untreated active Hepatitis B virus (HBV)
- •Treatment with any HCV anti-viral therapy within 4 weeks prior to Cycle 1 Day 1
结局指标
主要结局
-
the shrinkage estimator of objective response(OR) based on BHM
次要结局
- Adverse events (AEs), drug related AEs, drug related AEs leading to dose reduction or discontinuation(during treatment period)
- Disease control (DC)(from first treatment infusion until the earliest of disease progression, death or last evaluable tumor assessment before start of subsequent anti-cancer therapy, lost to follow-up or withdrawal of consent)
- Duration of objective response (DoR)(from first documented CR or PR until the earliest of disease progression or death among patients with OR)
- Pharmacokinetic parameters Cmax, tmax, AUC0-504h(after the first and fourth infusion cycle)
- Progression-free survival (PFS)(from first treatment infusion until disease progression or death from any cause, whichever occurs earlier)
- Tumour shrinkage (in millimeters)
研究者
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