A First-in-human Phase I, Open-label, Multicentre Trial of i.v. Administrations of BI 4060107 in Patients With Unresectable Advanced and/or Metastatic Solid Tumours
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 试验地点
- 6
- 主要终点
- Occurrence of dose limiting toxicity(ies) DLT(s) during the primary DLT evaluation period
研究概览
简要总结
This study is open to adults with advanced cancer who have selected types of solid tumours that cannot be surgically removed. People can join the study if they have tried all available treatments and have no other options. The purpose of this study is to find the highest dose of a medicine called BI 4060107 that people with advanced cancer can tolerate. In this study, BI 4060107 is given to humans for the first time.
Participants are divided into different dose groups based on when they join the study. Each participant within a dose group receives the same dose, with the lowest dose given to the first group. The next group receives a higher dose if the lower dose is tolerated.
Participants can stay in the study for up to 3 years if they benefit from the treatment and can tolerate it. During this time, they visit the study site regularly. After the first treatment, participants stay overnight for 1 night at the study site. At the visits, the doctors check the health of the participants and note any health problems that could have been caused by BI 4060107.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A patient must be ≥18 years of age and at least at the legal age of consent in countries where it is older than 18 years at the time of signature on the Informed Consent Forms (ICFs)
- •Signed and dated written main informed consent in accordance with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use - Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial
- •Patients with histologically or cytologically confirmed diagnosis of an unresectable advanced and/or metastatic or relapsed/refractory solid tumour.
- •Patients who have failed conventional treatment or for whom no therapy of proven efficacy exists or who are not eligible for established treatment options. The patient must have exhausted available treatment options as per local recommendations and reimbursement policies.
- •Further inclusion criteria apply
排除标准
- •Patients who have previously received an agent with the same target as the investigational medicinal product (IMP)
- •Treatment with a systemic anti-cancer therapy, an investigational device or an investigational drug within 28 days or 5 half-lives (whichever is shorter) of the first administration of trial medication
- •Radiotherapy within 28 days prior to first administration of trial medication except for palliative radiotherapy to regions other than the chest, or radiotherapy for brain metastases as described under the inclusion criteria in the protocol, is allowed if completed at least 14 days prior to first administration of trial medication
- •Current enrolment in another investigational device or drug trial
- •Further exclusion criteria apply
研究组 & 干预措施
Cohort 1: BI 4060107 dose level 1
干预措施: BI 4060107 (Biological)
Cohort 2: BI 4060107 dose level 2
干预措施: BI 4060107 (Biological)
Cohort 3: BI 4060107 dose level 3
干预措施: BI 4060107 (Biological)
Cohort 4: BI 4060107 dose level 4
干预措施: BI 4060107 (Biological)
Cohort 5: BI 4060107 dose level 5
干预措施: BI 4060107 (Biological)
结局指标
主要结局
Occurrence of dose limiting toxicity(ies) DLT(s) during the primary DLT evaluation period
时间窗: up to 21 days
次要结局
- Occurrence of adverse events (AEs) during the on-treatment period(up to 36 months)
- Occurrence of AE fulfilling DLT criteria during the on-treatment period(up to 36 months)
- Maximum measured concentration (Cmax) of pharmacokinetic (PK) parameters of BI 4060107(up to 4 days per cycle)
- Cmax of analyte I(up to 4 days per cycle)
- Cmax of analyte II(up to 4 days per cycle)
- Cmax of analyte III(up to 4 days per cycle)
- Area under the concentration-time curve of PK parameters of BI 4060107 over the time interval from 0 to the last quantifiable data point (AUC0-tz)(up to 4 days per cycle)
- Area under the concentration-time curve of analyte I over the time interval from 0 to the last quantifiable data point (AUC0-tz)(up to 4 days per cycle)
- Area under the concentration-time curve of analyte II over the time interval from 0 to the last quantifiable data point (AUC0-tz)(up to 4 days per cycle)
- Area under the concentration-time curve of analyte III over the time interval from 0 to the last quantifiable data point (AUC0-tz)(up to 4 days per cycle)
- Area under the concentration-time curve of PK parameters of BI 4060107 over the dosing interval τ (AUCτ)(up to 4 days per cycle)
- Area under the concentration-time curve of analyte I over the dosing interval τ (AUCτ)(up to 4 days per cycle)
- Area under the concentration-time curve of analyte II over the dosing interval τ (AUCτ)(up to 4 days per cycle)
- Area under the concentration-time curve of analyte III over the dosing interval τ (AUCτ)(up to 4 days per cycle)