Evaluating the efficacy and safety of Neoantigen Personalized Cancer Vaccine deepGeneAI-001 in combination with Sintilimab in the treatment of Gastrointestinal Solid Tumors
Voluntarily signs the informed consent form, and has good compliance.
Male or female, aged 18 years or older.
Patients with advanced gastrointestinal tumors: histologically and/or cytologically confirmed recurrent or metastatic gastrointestinal solid tumors not amenable to surgical or local curative treatment, with at least one measurable lesion as defined by RECIST v1.1. Eligible patients must have experienced disease progression following standard antitumor therapy or be unable or unwilling to receive standard treatment.
Neoantigen load requirement: at least 10 predicted neoantigen epitopes.
ECOG performance status of 0 or 1.
Life expectancy of at least 6 months.
Women of childbearing potential include premenopausal women and those within 2 years post-menopause.
A negative serum pregnancy test is required within 7 days before the first dose of the investigational product.
Single group
Neoantigen Personalized Cancer Vaccine
Biological/VaccineCohort 1: subjects will receive neoantigen tumor vaccine combination with Sintilimab. Cohort 2: subjects will receive neoantigen tumor vaccine combination with Sintilimab and chemotherapy .
Adverse events as graded by CTCAE v5.0
Serious adverse events as graded by CTCAE v5.0
Immunogenicity of a personalized cancer vaccine as measured by interferon-γ secreting T lymphocytes in peripheral blood mononuclear cells (PBMCs) using ELISpot
Cohort 1: Objective Response Rate (ORR) by RECIST 1.1
Cohort 1: Duration of Response (DOR)
Cohort 1: Disease Control Rate (DCR)
Cohort 1: Progression Free Survival (PFS) as assessed by RECIST 1.1
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Ruijin Hospital
Lead sponsor
deepGeneAI
Collaborator
Bio-X Institutes, Shanghai Jiao Tong University
Collaborator
