JPRN-jRCT2031220591招募中1 期
Phase Ia, first in human open label dose escalation trial evaluating intravenous BI 1703880 in combination with intravenous ezabenlimab for treatment of advanced solid tumours
Tsunoda Toru0 个研究点目标入组 66 人开始时间: 2023年1月27日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 66
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
- •Adult male or female patients with histologically or cytologically confirmed diagnosis of an advanced, unresectable, and/or metastatic malignant solid tumour
- •Patient must have exhausted or refused established treatment options known to prolong survival for the malignant disease, or is not eligible for established treatment options
- •Patient must have at least 1 lesion amenable to pre-treatment and on-treatment biopsy
- •ECOG 0 or 1 and life expectancy of at least >= 3 months after the start of the treatment according to the Investigator's judgement
- •Adequate organ function or bone marrow reserve as demonstrated at screening by laboratory values
排除标准
- •Any investigational or antitumour treatment within 4 weeks or 5 half-life periods prior to the first treatment whichever is shorter
- •Radiation therapy within 4 weeks prior to the first treatment
- •Prior STING agonist therapy
- •Prior intolerability of a PD-1 or anti-PD-L1 therapy
- •Immunosuppressive therapies including, but not limited to, systemic corticosteroids at doses exceeding >10 mg/day of prednisone or equivalent, and tumour necrosis factor-alpha blockers
- •Persistent toxicity from previous treatments (including irAEs) that has not resolved to Grade <=1, except for alopecia, xerostomia, and immunotherapy related endocrinopathies
- •History or evidence of active, non-treatment related autoimmune disease, except for endocrinopathies
- •History of pneumonitis related to prior immunotherapy
- •Positive and confirmed SARS-COV-2 test on Cycle 1 Day 1.
- •Presence of other active invasive cancers other than the one treated in this trial within 3 years prior to screening
- •Presence or history of uncontrolled or symptomatic brain or
- •subdural metastases unless local therapy has ended, and metastases considered stable for at least the prior three months
研究者
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