This is an open-label, dose escalation, phase I study to evaluate safety tolerability, MTD, pharmacokinetic profile, immunogenicity, and pharmacodynamic profile of Intravenous Administration of IDOV-SAFETM in patients with advanced solid tumors.
Age: from 18 to 75 years old.
At the time of screening, the patient had at least one measurable target lesion.
Patients with advanced solid tumors who have failed standard therapy during screening.
When screening, the ECOG score of physical strength score is 0 or 1.
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.
Patients with received allogeneic tissue or solid organ transplantation.
Sequential
IDOV-SAFE
Biological/VaccineIntravenous administration of oncolytic virus every 3 weeks until tumor progression
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
MTD
To explore the maximum tolerated dose (MTD)
Levels of viral DNA in blood
Peripheral blood was collected for viral DNA and live viral load measurement
Tumor markers
Blood samples are used to determine tumor markers.
T cell subsets
Analysis 1: Reactivation of memory T cells; Analysis 2: Multifunctional recovery of exhausted T cells.
Objective response rate
The sum of the proportion of subjects with Complete response or Partial response
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