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

Highlight Therapeutics, S.0 个研究点目标入组 69 人开始时间: 2020年9月17日最近更新: 2023年12月4日

适应症

试验速览

暂无简介。

•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 after at least 2 lines 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

•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.

发起方

Highlight Therapeutics, S.