This is a multicenter, open-label Phase 1 clinical study to evaluate the safety, tolerability, immunogenicity, pharmacokinetic (PK) and pharmacodynamic (PD) characteristics, as well as preliminary anti-tumor activity of ABO2102 as monotherapy and in combination among participants with solid tumors with KRAS mutations.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
101
mRNA encoding mutant KRAS neoantigens, administrated intramuscularly
Anti-PD-1 antibody, administered intravenously
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, China
RECRUITINGPart I: dose-limiting toxicities (DLT) with ABO2102 as monotherapy and in combination with Sintilimab
Time frame: 28 days after the first dose of study treatment
Part I: Incidence and severity of adverse events
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: ORR evaluated by investigators according to RECIST v1.1 criteria
Time frame: from the first dose of study treatment to up to 3 years
Part II: PFS evaluated by investigators according to RECIST v1.1 criteria
Time frame: from the first dose of study treatment to up to 3 years
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