jRCT2080225308尚未招募1 期
A First-in-human Phase I, non-randomized, open-label, multi-center dose escalation trial of BI 764532 administered by repeated intravenous infusions in patients with Small Cell Lung Carcinoma and other neuroendocrine neoplasms expressing DLL3
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Number of patients with DLTs in the MTD evaluation period
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 干预模型
- Open label trial with a dose finding phase
- 主要目的
- Treatment Purpose
入排标准
- 年龄范围
- 20age old over 至 No limit（—）
- 性别
- All
入选标准
- •Signed and dated, written informed consent form (ICF2) in accordance with ICH-GCP and local legislation prior to any trial-specific procedures, sampling, or analyses.
- •Locally advanced or metastatic cancer not amenable to curative treatment; of following histologies:
- •Small cell lung carcinoma (SCLC)
- •Large cells neuroendocrine lung carcinoma(LCNEC)
- •Neuroendocrine carcinoma (NEC) or small cell carcinoma of any other origin
- •Tumours must be positive for DLL3 expression (on archived tissue or in-study biopsy) according to central pathology review in order to start BI
- •Patient has failed or is not eligible for available standard therapies according to local guidelines. Standard therapies should include at least one line of chemotherapy that should include platinum for patients with small cells carcinoma tumors histologies.
- •For back-fill cohorts only: patient has agreed to and signed an IC to provide pre-treatment and on-treatment fresh tumor biopsy (fresh pre- and on-treatment biopsies are optional for main dose escalation patients).
- •At least one evaluable lesion outside of CNS as defined per modified RECIST 1.
- •Adequate liver, bone marrow and renal organ function
排除标准
- •Previous treatment with T cells engagers or cell therapies targeting DLL
- •Anticoagulant treatment that cannot be safely interrupted based on opinion of the investigator if medically needed (e.g. biopsy).
- •Persistent toxicity from previous treatments that has not resolved to <= CTCAE Grade1 (except for alopecia, CTCAE Grade 2 neuropathy, asthenia/fatigue or grade 2 endocrinopathies controlled by replacement therapy).
- •Patient has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of BI
- •Physiological replacement of steroids is allowed.
- •Prior anti-cancer therapy:
- •Patients who have been treated with any other anti-cancer drug within 3 weeks or within 5 half-life periods (whichever is shorter) prior to first administration of BI
- •Patients who have been treated with extensive field radiotherapy including whole brain irradiation within 2 weeks prior to first administration of BI
- •Women who are pregnant, nursing/breast feeding or who plan to become pregnant or nurse while in the trial or within 3 months after the last dose of study treatment.
结局指标
主要结局
Number of patients with DLTs in the MTD evaluation period
时间窗: MTD evaluation period
safety
Maximum tolerated dose (MTD) in any studied regimen
safety
次要结局
- Cmax
- AUCtau
- Objective response based on RECIST 1.1 criteria
研究者
研究点 (1)
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