EUCTR2019-004624-38-ES进行中（未招募）1 期
Phase IIa open-label clinical study of intratumoural administration of BO-112 in combination with pembrolizumab in subjects with liver metastasis from colorectal cancer or gastric/gastro-oesophageal junction cancer
Bioncotech Therapeutics, S.0 个研究点目标入组 69 人开始时间: 2020年3月6日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 69
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Be willing and able to give written informed consent for the study.
- •2.Be equal or greater than 18 years of age.
- •3.Have nonresectable liver metastasis(es) of colorectal or gastric/gastro-oesophageal junction cancer (GC/GEJ).
- •4.Have progressed during or after, or have not tolerated therapy for advanced/metastatic disease as follows. Colorectal cancer: at least 2 lines of prior therapy (1 line if hepatic recurrence after resection). Gastric or gastro-oesophageal cancer: at least 1 line of prior therapy .
- •5.Have at least 1 liver metastasis of minimum 20 mm in diameter that is suitable for intratumoural injection.
- •6.Presence of at least 1 measurable lesion according to RECIST v1.1.
- •7.Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- •8.Adequate haematologic and end-organ function within 2 weeks prior to the first dose of study treatment
- •9.Female subjects who are not pregnant or breastfeeding and at least 1 of the following conditions applies:
- •a)Not a woman of childbearing potential (WOCBP)
- •b)WOCBP who agrees to follow contraception guidance during the treatment period and for at least 120 days after the last dose of study treatment.
- •10.Able and willing to comply with study and follow-up procedures.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 35
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 34
排除标准
- •1.Prior treatment with an immune checkpoint inhibitor, an agent directed to another stimulatory or co-inhibitory T-cell receptor or any Toll-like receptor (TLR) agonist.
- •2.Liver metastasis(es) with macroscopic tumour infiltration into the main portal vein, hepatic vein or vena cava.
- •3.Contraindications to tumour biopsy and injections of the hepatic metastasis(es).
- •4.Chemotherapy, definitive (curative) radiation, or biological cancer therapy within 4 weeks prior to the first dose of study treatment.
- •5.Clinically active central nervous system metastases and/or carcinomatosis meningitis.
- •6.Life expectancy of < 12 weeks.
- •7.Active infection requiring systemic therapy.
- •8.History of (non-infectious) pneumonitis that required steroids or current pneumonitis.
- •9.Active autoimmune disease that required systemic treatment in past 2 years.
- •10.Known human immunodeficiency virus (HIV) infection.
- •11.Known history of hepatitis B or known active hepatitis C virus infection.
- •12.For WOCBP: pregnancy or a positive urine pregnancy test (eg within 72 hours) prior to treatment; or breastfeeding.
- •13.Any other medical condition which would impact the safety of the subject or interfere with the subject’s ability to comply with the study and follow-up procedures.
- •14.Is currently participating or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment.
研究者
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