The purpose of this study is to assess the safety, feasibility, and efficacy of personalized mRNA vaccine iNeo-Vac-R01 alone in subjects with advanced digestive system neoplasms.
Male or female, >/= 18 years old and </= 75 years old, with the ability to understand and provide signed and witnessed informed consent, and agree and are able to comply with protocol requirements.
Subjects must have one of the histologically- or cytologically-confirmed advanced (locally advanced or metastatic) digestive system neoplasms, have measurable disease at study entry defined by RECIST v1.1. Subjects must have tumor progression after standard treatment or are intolerant or are unwilling to receive standard treatment. The toxic effects of previous anti-tumor treatments have returned to </= grade 1 defined by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0 or to the level specified by the inclusion/
Expected survival >/= 6 months.
Eastern Cooperative Oncology Group (ECOG) performance status score of 0 ~ 2.
Sufficient tumor tissue samples can be obtained from subjects for genetic analysis, with at least 2 puncture tissues with a tumor purity of ≥ 50% required for puncture samples and at least 0.5cm of tissue required for surgical samples. Alternatively, the original gene sequencing data required for tumor neoantigen analysis can be provided, including full exon sequencing data of tumor tissue, transcriptome sequencing data, and full exon sequencing data of peripheral blood.
Echocardiographic evaluation: left ventricular ejection fraction (LVEF) >/= 50%.
Single group
iNeo-Vac-R01
Biological/VaccinePersonalized mRNA vaccine encoding neoantigen, IH injection
Number of Participants with Adverse Events (AEs) [safety and tolerability]
Proportion of Subjects Receiving iNeo-Vac-R01 Injection Treatment to Enrolled Subjects [feasibility]
Dose-limiting Toxicity (DLT)
Level 3 or 4 AEs related to iNeo-Vac-R01 injection.
Overall Survival (OS)
OS is defined as time between the date of the first dose of iNeo-Vac-R01 and the date of death due to any cause.
Objective Response Rate (ORR)
ORR is defined as proportion of subjects with complete response (CR) and partial response (PR) to all subjects based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Disease Control Rate (DCR)
DCR is defined as proportion of subjects with reduced or stable neoplasms that have been maintained for a certain period of time, including the proportion of subjects with CR, PR, and stable disease (SD).
Duration of Response (DOR)
DOR is defined as time from first PR or CR until either disease progression or death (whichever is sooner).
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Sir Run Run Shaw Hospital
Lead sponsor
Hangzhou Neoantigen Therapeutics Co., Ltd.
Collaborator
