Study of ABO2102 in KRAS-Mutated Solid Tumors
Condition(s) studied
Investigational drug(s) / intervention(s)
ABO2102 Injection: mRNA encoding mutant KRAS neoantigens, administrated intramuscularly
Sintilimab injection: Anti-PD-1 antibody, administered intravenously
Study summary
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.
Eligibility
Primary outcome measure(s)
- Part I: dose-limiting toxicities (DLT) with ABO2102 as monotherapy and in combination with Sintilimab — 28 days after the first dose of study treatment
- Part I: Incidence and severity of adverse events — 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 — from the first dose of study treatment to up to 3 years
- Part II: PFS evaluated by investigators according to RECIST v1.1 criteria — from the first dose of study treatment to up to 3 years
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Ruijin Hospital, Shanghai Jiao Tong University School of Medicine | Shanghai | China | Recruiting |
More Suzhou Abogen Biosciences Co., Ltd. trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07455617 on ClinicalTrials.gov ↗ ← All trials in China