Status:
RECRUITING
Study of KRAS Neoantigen mRNA Vaccine (ABO2102) in Patients With KRAS -Mutated Solid Tumors
Lead Sponsor:
Ruijin Hospital
Collaborating Sponsors:
Suzhou Abogen Biosciences Co., Ltd.
Conditions:
Pancreatic Neoplasms
Other Solid Tumors
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
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 toripalim...
Eligibility Criteria
Inclusion
- ≥18 years of age at time of informed consent.
- 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.
- Harboring at least one of the targeted KRAS mutants.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0\~2.
- Life expectancy of ≥12 weeks.
- Sufficient organ function.
Exclusion
- Any other prior malignancy active within the previous 5 years, except for skin basal cell cancer that have been cured, superficial bladder cancer, or carcinoma in situ of the breast or cervix.
- Received KRAS cancer vaccine before.
- Immunosuppressants or other immunomodulatory drugs were required within 4 weeks before the first dose of study treatment. Physiological doses of systemic steroids or topical medications are allowed. Topical medications should not exceed the dose recommended in the package insert or have any systemic exposure signs; Or patients with other acquired or congenital immunodeficiency diseases, or a history of organ transplantation who need to use immunosuppressants or other immunomodulatory drugs.
- History of severe allergies or known allergies to any active or inactive component of the study drug(s).
- Uncontrolled systemic infection; active tuberculosis.
- Severe cardiovascular diseases.
- Has known symptomatic, untreated central nervous system metastases, or CNS metastases requiring continued treatment. Participants with asymptomatic brain metastases and who do not require treatment are eligible for enrolment.
- Have active autoimmune and inflammatory diseases.
- Have immediate hypersensitivity, a history of eczema or asthma uncontrolled by topical corticosteroids.
- Have other serious medical conditions
- A history of organ transplantation, bone marrow transplantation or hematopoietic stem cell transplantation.
Key Trial Info
Start Date :
September 24 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2027
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT06577532
Start Date
September 24 2024
End Date
August 1 2027
Last Update
May 21 2025
Active Locations (1)
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1
Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, China