Based on the activation and regulation of immune system by cytokines, mRNA encoding cytokines has become one of the important directions of mRNA tumor drug development. This product (ABOD2011) is a new generation mRNA product for intratumoral injection.
The primary objective of this study is to assess the safety and tolerability, of ABOD2011 in patients with advanced solid tumors that progressed after standard systemic therapy.
18 years and older.
Understand and voluntarily sign the informed consent form (ICF).
Histopathologically confirmed recurrent or metastatic solid tumors.
Failure of prior systemic standard of care, or intolerance to severe toxicity, or lack of standard of care.
Any systemic anti-tumor therapy, within 28 days prior to the first dose.
Radiotherapy within 14 days prior to first dose.
Use of immunosuppressants.
Major surgery within 28 days.
Parallel
human single chain IL-12 mRNA-single dose
Biological/Vaccinehuman single chain IL-12 mRNA administered as specified in the treatment arm with injection once only
human single chain IL-12 mRNA-multiple dose
Biological/Vaccinehuman single chain IL-12 mRNA administered as specified in the treatment arm with injection once per week for 3 weeks
Number of Participants Experiencing dose-limiting toxicities (DLTs)
Number of Participants Experiencing dose-limiting toxicities (DLTs)
Number of Participants Experiencing Adverse Events (AEs)
Number of Participants Experiencing Adverse Events (AEs)
Number of Participants Experiencing Severe Adverse Events (SAEs)
Number of Participants Experiencing Severe Adverse Events (SAEs)
Overall Response Rate (ORR)
Overall Response Rate (ORR)
Disease Control Rate(DCR)
Disease Control Rate(DCR)
Duration of Response (DOR)
Duration of Response (DOR)
Progression-Free Survival (PFS)
Progression-Free Survival (PFS)
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