Actively Recruiting
Study of KRAS Neoantigen mRNA Vaccine (ABO2102) in Patients With KRAS -Mutated Solid Tumors
Led by Ruijin Hospital · Updated on 2025-05-21
56
Participants Needed
1
Research Sites
148 weeks
Total Duration
On this page
Sponsors
R
Ruijin Hospital
Lead Sponsor
S
Suzhou Abogen Biosciences Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study of KRAS Neoantigen mRNA Vaccine (ABO2102) in Patients With KRAS -Mutated Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years of age or older at the time of informed consent
- Histologically or cytologically confirmed advanced solid tumors, including pancreatic ductal adenocarcinoma or non-small cell lung cancer, with disease progression or intolerance to at least one systemic treatment
- Presence of at least one targeted KRAS mutation
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Life expectancy of at least 12 weeks
- Adequate organ function
You will not qualify if you...
- Any other active malignancy within the past 5 years except cured skin basal cell cancer, superficial bladder cancer, or carcinoma in situ of the breast or cervix
- Previous treatment with a KRAS cancer vaccine
- Use of immunosuppressants or immunomodulatory drugs within 4 weeks before study treatment, except permitted physiological doses of systemic steroids or topical medications
- Acquired or congenital immunodeficiency or history of organ transplantation requiring immunosuppressants
- History of severe allergies or known allergies to components of the study drugs
- Uncontrolled systemic infection or active tuberculosis
- Severe cardiovascular disease
- Symptomatic, untreated central nervous system metastases or CNS metastases requiring ongoing treatment
- Active autoimmune or inflammatory diseases
- Immediate hypersensitivity, eczema, or asthma uncontrolled by topical corticosteroids
- Other serious medical conditions
- History of organ, bone marrow, or hematopoietic stem cell transplantation
AI-Screening
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Trial Site Locations
Total: 1 location
1
Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, China
Actively Recruiting
Research Team
X
Xinjing Wang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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