Study of KRAS Neoantigen mRNA Vaccine (ABO2102) in Patients With KRAS -Mutated Solid Tumors
Trial Parameters
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. ≥18 years of age at time of informed consent. 2. Participants with histologically and/ or cytologically confirmed advanced solid tumors (such as pancreatic ductal adenocarcinoma, non-small cell lung cancer, etc.), whose disease has progressed or being intolerant to relevant treatments during or following at least one line of systemic treatment; patients in the second stage include those who have experienced disease progression or intolerance to previous systemic treatments, as well as those who have not received systemic therapy but are deemed by the investigator to potentially benefit from the study treatment based on a comprehensive clinical assessment. 3. Harboring at least one of the targeted KRAS mutants. 4. Eastern Cooperative Oncology Group (ECOG) performance status score of 0\~2. 5. Life expectancy of ≥12 weeks. 6. Sufficient organ function. Exclusion Criteria: 1. Any other prior malignancy active within the previous 5 years, except for skin basal cell ca