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New treatment option for Pancreatic Neoplasms
Official title Study of KRAS Neoantigen mRNA Vaccine (ABO2102) in Patients With KRAS -Mutated Solid Tumors
ClinicalTrials.gov ID: NCT06577532
What this study is testing
What is ABO2102?
ABO2102 is an investigational medicine, given as an injection into a muscle, being studied as a potential treatment for pancreatic neoplasms.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- ≥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...
- 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.
You likely can't join if
- Any other prior malignancy active within the previous 5 years, except for skin basal cell cancer that have been cured, superficial bladder cancer, or...
- 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...
- 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.
See the full eligibility criteria
- ≥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...
- 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.
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.