Phase I, non-randomised, open-label, multi-centre dose escalation and expansion trial of BI 765049 and BI 765049 + ezabenlimab administered by repeated intravenous infusion in Asian patients with malignant solid tumours expressing B7-H6
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 70
- 主要终点
- Occurrence of DLTs during the MTD evaluation period for BI 765049 monotherapy
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
- Non-randomized Controlled Trial
- 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（—）
入选标准
- •. >=18 years of age.
- •. Histologically or cytologically confirmed diagnosis of an advanced, unresectable, and/or metastatic GC, CRC, PDAC, HCC, HNSCC, or NSCLC.
- •. Agree to the collection of tumour samples (as slides from archival diagnostic samples or fresh tumour biopsies) for confirmation of B7-H6 expression
- •. Confirmed B7-H6 expression on tumour tissue sample (archived or fresh tumour biopsy) based on central pathology review except for patients diagnosed with advanced or metastatic CRC
- •. Patient who has failed conventional treatment or for whom no therapy of proven efficacy exists or who is not eligible for established treatment options.
- •. Evaluable target lesion for response assessment outside of the central nervous system as defined per RECIST v1.
- •. Adequate organ function as specified in Section 3.3.2
排除标准
- •. Any investigational or antitumour treatment within 21 days or 5 half-life periods prior to the first treatment, whichever is shorter.
- •. Previous treatment with a B7-H6 targeting agent
- •. For Parts III and IV, prior intolerable toxicity (as judged by the Investigator) to PD-1 or anti-PD-L1 therapy.
- •. Diagnosis of immunodeficiency within 7 days prior to the first dose of BI 765049
- •. History of immunosuppressive medication within 14 days prior to the first dose of BI 765049, with some exceptions
- •. Persistent toxicity from previous treatments (including irAEs) that has not resolved to Grade 1, except for alopecia, Grade 2 neuropathy, or endocrinopathies controlled by replacement therapy
- •. Evidence of active, non-treatment related autoimmune disease, with some exceptions.
- •. History of/active non-infectious pneumonitis or interstitial lung disease of any grade
- •. Infection requiring systemic antimicrobial, antiviral, antiparasitic or antifungal therapy at the start of treatment in the trial.
结局指标
主要结局
Occurrence of DLTs during the MTD evaluation period for BI 765049 monotherapy
时间窗: MTD evaluation period
Part I: Occurrence of DLTs during the MTD evaluation period for BI 765049 monotherapy
Occurrence of DLTs during the MTD evaluation period for BI 765049 in combination with ezabenlimab
时间窗: MTD evaluation period
Part III: Occurrence of DLTs during the MTD evaluation period for BI 765049 in combination with ezabenlimab
Objective response based on RECIST (v1.1)
时间窗: From the first administration of trial medication until the earliest of progressive disease (PD), death, last evaluable tumour assessment before the start of subsequent anti-cancer therapy, lost to follow-up, or withdrawal of consent
Parts II and Part IV: Objective response based on RECIST (v1.1) as determined by the Investigator in patients with measurable disease, defined as the best overall response of complete response (CR) or partial response (PR), from the first administration of trial medication until the earliest of progressive disease (PD), death, last evaluable tumour assessment before the start of subsequent anti-cancer therapy, lost to follow-up, or withdrawal of consent.
次要结局
- PK parameters of BI 765049
- Objective response (RECIST v1.1)(from the first administration of trial medication until the earliest of PD, death, or last evaluable tumour assessment before the start of subsequent anti-cancer therapy, lost to follow-up, or withdrawal of consent)
- PFS(from first treatment administration until tumour progression or death from any cause)
- Duration of response(from a patient's first documented CR or PR until the earliest of disease progression or death)
- Disease control(from the first administration of trial medication until the earliest of PD, death, or last evaluable tumour assessment before start of subsequent anti-cancer therapy, lost to follow-up, or withdrawal of consent)
- Objective response (iRECIST)(from the first administration of trial medication until the earliest of immune-confirmed PD, death, or last evaluable tumour assessment before start of subsequent anti-cancer therapy, lost to follow-up, or withdrawal of consent)