This is an open-label, dose escalation, phase I study to evaluate safety tolerability, MTD, pharmacokinetic profile, immunogenicity, and pharmacodynamic profile of intratumoral Administration of IDOV-SAFETM in patients with advanced solid tumors.
18 ~75 years old, gender is not limited;
During screening, patients with advanced malignant solid tumors confirmed by histology or cytology (mainly including breast cancer (triple-negative priority), melanoma, head and neck tumors, and gastrointestinal cancers such as colorectal cancer, cholangiocarcinoma, pancreatic cancer, and liver cancer with intratumoral injection conditions).
At the time of screening, the disease has progressed after or during standard treatment; Or subjects with advanced malignant solid tumors who currently have no standard treatment available or are intolerant to chemotherapy.
Tumor lesions and/or metastases with at least one evaluable lesion that is subcutaneously accessible or can be injected under imaging guidance, according to the solid tumor response criteria (RECIST version 1.1).
At the time of screening, advanced malignant tumors have a chance of being cured by radical treatment.
Asymptomatic brain metastases such as untreated ones at the time of screening; Subjects with symptomatic central nervous system (CNS) metastatic or cancerous meningitis; Or there was other evidence of uncontrolled central nervous system or meningeal metastases in subjects who were judged by the investigator to be unsuitable for enrollment.
Prior to enrollment, there was severe chronic or active infection: active hepatitis B (HbsAg positive, HBV DNA test value greater than the upper limit of normal); Active hepatitis C (those with positive anti-HCV antibodies are further tested positive for HCV RNA); A known history of immunodeficiency virus (HIV) disease or a positive HIV antibody test; Other conditions requiring systemic anti-infective treatment in the 4 weeks prior to initial use of the investigational drug include, but are not limited to, hospitalization for infectious complications, bacteremia, severe pneumonia, or active tuberculosis.
At the time of screening, patients had a history of active autoimmune diseases such as systemic lupus erythematosus, rheumatoid arthritis, vasculitis, etc., or were receiving long-term systemic steroids (prednisone >10mg/ day or equivalent doses of the same drug) or any other form of immunosuppressant therapy within 4 weeks prior to the first use of the study drug.
Sequential
IDOV-SAFETM
Biological/VaccineEach patient received intratumoral injection on the first day, 14 days as a course of treatment, and the follow-up investigator decided whether to continue the second (D14) and third (D28) course of administration according to the comprehensive evaluation of the subjects' conditions
Dose Limiting Toxicities (DLT)
Dose-limiting toxicity is defined as an adverse event that is considered to be drug-related and meets one of the Protocol definitions
Incidence of adverse events (AE)
Incidence of adverse events (AE)
Levels of viral DNA in blood
Peripheral blood was collected for viral DNA and live viral load measurement
T cell subsets
Analysis 1: Reactivation of memory T cells; Analysis 2: Multifunctional recovery of exhausted T cells.
Tumor infiltrates lymphocytes
Tumor tissue samples were immunohistochemically stained with anti-CD8 antibodies, and then tumor infiltrating lymphocytes were analyzed.
TCR spectrum analysis
Blood and tumor tissue samples were used for TCR analysis. For tumor tissue samples, samples taken by biopsy during this clinical trial were used.
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