The purpose of this study is to evaluate the safety, immunogenicity, pharmacodynamics, as well as preliminary efficacy of KRAS neoantigen mRNA vaccine (ABO2102) alone and in combination with toripalimab (anti-PD-1 monoclonal antibody) among participants with KRAS-mutated advanced pancreatic cancer and other solid tumors. The trial includes dose escalation (Part I) and dose expansion(Part II) parts.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
56
mRNA encoding mutant KRAS neoantigens, administrated intramuscularly
Anti-PD-1 antibody, administered intravenously
Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, China
RECRUITINGPart I: The incidence and nature of dose-limiting toxicity (DLT) for ABO2102 as monotherapy or in combination with toripalilmab.
Time frame: 21 days after the first dose of study treatment
Part I: The incidence and severity of treatment-emergent adverse events (TEAE)s.
Time frame: from the first dose of study treatment to 30 days after the last dose of monotherapy or to 90 days after the last dose of the combination therapy.
Part I: The incidence and severity of serious TEAEs (TESAE)s.
Time frame: from the first dose of study treatment to 30 days after the last dose of monotherapy or to 90 days after the last dose of the combination therapy.
Part I: The incidence and severity of TEAEs leading to interruption or early termination of study treatment.
Time frame: from the first dose of study treatment to 30 days after the last dose of monotherapy or to 90 days after the last dose of the combination therapy.
Part II: Overall Response Rate (ORR) per RECIST version 1.1.
Time frame: from the first dose of study treatment to up to 2 years.
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