A Phase I, Open-label, Non-randomised, Multi-center Dose Escalation Trial of BI 765049 Administered by Parenteral Route in Patients With Advanced, Unresectable, and/or Metastatic Colorectal Carcinoma (CRC), Gastric Carcinoma (GC), or Pancreatic Ductal Adenocarcinoma (PDAC) to Determine the MTD and the RP2D and to Determine the Dosing Regimen for Further Development of BI 765049
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 14
- 试验地点
- 6
- 主要终点
- Occurrence of dose limiting toxicities (DLTs) in the maximum tolerated dose (MTD) evaluation period
研究概览
简要总结
This study is open to adults with advanced cancer of the colon, rectum, stomach, or pancreas, that is the cancer cannot be removed by surgery or has spread. People can take part in this study if their previous treatment was not successful, or no other treatment exists.
The study aims to find the highest dose for the study medicine called BI 765049 that people with advanced cancer can tolerate. Another purpose is to find the most suitable dose and best way of administration of BI 765049 for further clinical development. BI 765049 may help the immune system fight cancer.
Participants receive BI 765049 at least once every 3 weeks. Participants may continue to get BI 765049 treatment as long as they benefit from treatment and can tolerate it. Participants in this study also get additional medication before and after treatment with BI 765049 for better tolerability. If participants take this medication at home, they have daily phone visits.
Participants regularly visit the study site. The study visits include several overnight stays at the hospital. At the visits, study doctors check participants' health, take necessary laboratory tests, and note any unwanted effects. Unwanted effects are any health problems that the doctors think were caused by the study medicine or treatment. To find the highest dose of BI 765049 that participants can tolerate, researchers look at the number of participants with certain severe health problems. These are severe health problems that happen within the time from when a person first receives the intended target dose, until one week after they receive it for the second time.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •For all patients, signed and dated informed consent form (ICF)2/main ICF describing the study in accordance with International Council on Harmonisation Good Clinical Practice (ICH-GCP) and local legislation prior to any trial-specific procedures, sampling, or analyses.
- •Patient must be ≥18 years of age and at least at the legal age of consent in countries where it is greater than 18 years at the time of signature on the ICFs (ICF1/screening ICF and ICF2/main ICF).
- •In US: Patients with a histologically or cytologically confirmed diagnosis of colorectal carcinoma (CRC), gastric carcinoma (GC), or pancreatic ductal adenocarcinoma (PDAC).
- •In Europe: Patients with a histologically or cytologically confirmed diagnosis of CRC.
- •Patients with advanced, unresectable, and/or metastatic disease. Further inclusion criteria apply.
排除标准
- •Patient with a history of a major surgery within 28 days prior to first dose of BI 765049 (major according to the Investigator's and/or Medical Monitor's assessment).
- •Previous or concomitant malignancies other than the one treated in this trial within the last 5 years except:
- •Effectively treated non-melanoma skin cancers
- •Effectively treated carcinoma in situ of the cervix
- •Effectively treated ductal carcinoma in situ
- •Other effectively treated malignancy that is considered cured by local treatment"
- •Patient with known leptomeningeal disease or spinal cord compression due to disease.
- •Patient requiring anticoagulant treatment which cannot be safely interrupted, if medically needed based on the opinion of the Investigator.
- •Further exclusion criteria apply.
研究组 & 干预措施
Part 1 (Administration Regimen A)
干预措施: BI 765049 (Drug)
Part 2 (Administration Regimen B)
干预措施: BI 765049 (Drug)
结局指标
主要结局
Occurrence of dose limiting toxicities (DLTs) in the maximum tolerated dose (MTD) evaluation period
时间窗: up to 36 months
次要结局
- Occurrence of DLTs and adverse events during the entire treatment period(up to 36 months)
- Maximum measured concentration (Cmax) of BI 765049 after first administration(up to 4 days)
- Maximum measured concentration (Cmax) of BI 765049 after multiple administrations(up to 20 days)
- Area under the concentration-time curve of BI 765049 over a uniform dosing interval τ (AUCτ) after first administration(up to 4 days)
- Area under the concentration-time curve of BI 765049 over a uniform dosing interval τ (AUCτ) after multiple administrations(up to 20 days)
- Objective response (OR)(up to 36 months)