KRAS neoantigen mRNA vaccine for 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

This study is testing a new mRNA vaccine for patients with advanced solid tumors that have KRAS mutations to see if it can help them when used alone or with another treatment.

Quick facts

• Phase: EARLY_PHASE1
• Study type: Interventional
• Enrollment: 56 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Ruijin Hospital (other)
• Drugs / interventions: toripalimab
• Locations: 1 site (Shanghai)
• Trial ID: NCT06577532 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and effectiveness of the KRAS neoantigen mRNA vaccine (ABO2102) in patients with advanced solid tumors, particularly those with KRAS mutations. It involves a dose escalation phase to determine the optimal dosage and a dose expansion phase to further assess the vaccine's efficacy when used alone and in combination with toripalimab, an anti-PD-1 monoclonal antibody. Participants must have advanced solid tumors that have progressed after previous treatments or are intolerant to them.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with advanced solid tumors harboring KRAS mutations who have experienced disease progression or intolerance to prior treatments.

Not a fit: Patients with active malignancies other than skin basal cell carcinoma within the last five years may not benefit from this study.

Why it matters

Potential benefit: If successful, this vaccine could provide a new treatment option for patients with KRAS-mutated cancers, potentially improving their outcomes.

How similar studies have performed: While the approach of using mRNA vaccines in cancer treatment is emerging, this specific application targeting KRAS mutations is relatively novel and has not been extensively tested in prior studies.

Eligibility criteria

Inclusion Criteria:

1. ≥18 years of age at time of informed consent.
2. 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.
3. Harboring at least one of the targeted KRAS mutants.
4. Eastern Cooperative Oncology Group (ECOG) performance status score of 0\~2.
5. Life expectancy of ≥12 weeks.
6. Sufficient organ function.

Exclusion Criteria:

1. 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.
2. Received KRAS cancer vaccine before.
3. 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.
4. History of severe allergies or known allergies to any active or inactive component of the study drug(s).
5. Uncontrolled systemic infection; active tuberculosis.
6. Severe cardiovascular diseases.
7. 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.
8. Have active autoimmune and inflammatory diseases.
9. Have immediate hypersensitivity, a history of eczema or asthma uncontrolled by topical corticosteroids.
10. Have other serious medical conditions
11. A history of organ transplantation, bone marrow transplantation or hematopoietic stem cell transplantation.

Where this trial is running

Shanghai

• Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine — Shanghai, China (RECRUITING)

Study contacts

• Principal investigator: Baiyong Shen — Ruijin Hospital
• Study coordinator: Xinjing Wang

Conditions: Pancreatic Neoplasms, Other Solid Tumors