NCT06577532RecruitingEarly phase 1
Study of KRAS Neoantigen mRNA Vaccine (ABO2102) in Patients With KRAS -Mutated Solid Tumors
A Clinical Study to Investigate Safety, Tolerability, Immunogenicity, and Preliminary Efficacy of mRNA Nanoparticles Encoding KRAS Neoantigens (ABO2102) in Participants With KRAS-mutated Advanced Pancreatic Cancer And Other Solid Tumors
Source: ClinicalTrials.gov · Last updated 21 May 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 56 (estimated)
- First submitted
- 22 Aug 2024
- Start date
- 24 Sept 2024
- Primary completion date
- Dec 2026
- Lead sponsor
- Ruijin Hospital
- Diseases
- Pancreatic cancer
- NCT number
- NCT06577532
What you commit to
- Study type: Interventional · Early phase 1
- Planned participants: 56
- From 24 Sept 2024 to the primary completion date, Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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.
- 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.
- 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.
Other
- 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.
Who the study is looking for
- ≥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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.