Study of KRAS Neoantigen mRNA Vaccine (ABO2102) in Patients With KRAS -Mutated Solid Tumors

Launched by RUIJIN HOSPITAL · Aug 27, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment for patients with advanced pancreatic cancer that has a specific genetic change known as a KRAS mutation. The researchers are testing an experimental vaccine called ABO2102, which aims to help the immune system recognize and fight cancer cells. Some participants will receive this vaccine on its own, while others will receive it along with another drug called toripalimab, which helps boost the immune response. The study is currently recruiting participants who are at least 18 years old and have had their cancer worsen after at least one previous treatment.

To join the trial, patients must have confirmed advanced pancreatic cancer with a KRAS mutation and a good overall health status, meaning they can carry out daily activities with minimal assistance. Participants will not be able to take part if they have certain other health conditions or have had specific treatments recently. If eligible, those who take part can expect close monitoring to ensure their safety while assessing how well the vaccine works against their cancer. This trial represents a hopeful step in finding new treatment options for this challenging disease.

Gender

ALL

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.