Personalized neoantigen peptide vaccine for advanced solid cancer

Chulalongkorn University0 个研究点目标入组 35 人开始时间: 2019年10月3日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•- Age > 18 years
•- Written consent on an IRB/IEC-approved Informed Consent Form (ICF) prior to any study-specific evaluation
•- The life expectancy of at least 3 months
•- Eastern Cooperative Oncology (ECOG) performance status of 0 to 1
•- Criteria specific to each tumor type:
•- For NSCLC: Histologically confirmed the diagnosis of unresectable or
•metastatic NSCLC â€¨
•- For CRC: Histologically confirmed the diagnosis of metastatic colorectal cancerâ€¨
•- For melanoma: Histologically confirmed the diagnosis of metastatic ovarian
•- For pancreatic cancer: Histologically confirmed the diagnosis of unresectable
•or metastatic pancreatic cancerâ€¨
•- Provide either a newly obtained or archival tissue sample sufficient for neoantigen peptide vaccine development. Newly obtained tissue is preferred.
•- Adequate organ function

•- History of severe hypersensitivity reaction to any peptide vaccines.
•- Any active or suspected autoimmune diseases or a documented history of autoimmune disease, or history of a syndrome that required systemic steroids or immunosuppressive medications, except for subjects with vitiligo or resolved childhood asthma/atopy.
•- Prior immunotherapy including cell-based therapy, anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways within 3 months before the first dose of the study drug.

发起方