Phase 1 Pancreatic Cancer Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• You are 18 years of age or older
• You have been diagnosed with pancreatic or colon cancer that has been confirmed through a tissue or cell sample (biopsy or lab test)
• You have at least one tumor that can be safely biopsied more than once, and you are willing to have a tumor biopsy at the start of the study and during treatment
• Your cancer can be measured on a scan using standard medical criteria (called RECIST 1.1)
• There is enough tumor tissue available for specialized genetic and immune testing
• Your tumor has a specific type of gene change (KRAS mutation) that is included in the vaccine being studied
• Pancreatic cancer group (Cohort A): You have received 4–6 months of a specific chemotherapy regimen (FOLFIRINOX or gemcitabine+nab-paclitaxel) as your first treatment for advanced, inoperable pancreatic cancer
• Colon cancer group (Cohort B): You have received 4–6 months of a standard first-line chemotherapy regimen for advanced colorectal cancer, which may have included targeted therapy
• Third group (Cohort C): You have received no more than 3 rounds of chemotherapy treatments in total, including a KRAS-targeting drug
• You are fully active and able to carry out normal daily activities without restriction (confirm with trial site for exact definition)
• Your doctor expects you to live for more than 3 months
• Your liver, kidneys, bone marrow, and other organs are functioning well enough based on blood tests
• If you are a woman who could become pregnant, you have a negative pregnancy test and are willing to use contraception as required by the study
• If you are a man, you are willing to use an acceptable form of birth control during the study
• You are able to understand the study and are willing to sign a consent form

Who may not be able to join:

• Your cancer could potentially be removed with surgery
• You have cancer that has spread to the brain or the lining around the brain or spinal cord
• You have previously received immunotherapy treatments (such as checkpoint inhibitors like anti-PD-1 or anti-CTLA-4 drugs)
• You are currently taking medications that suppress your immune system, or have used steroid medications regularly within the past 14 days before starting the vaccine
• You have an active autoimmune disease that has needed treatment in the past 5 years, a history of a severe autoimmune condition, or a condition requiring ongoing steroids or immune-suppressing drugs
• You have a known history of, or currently have, a lung condition called interstitial lung disease
• Your blood oxygen level measured by a finger sensor is below 95% while breathing normal room air
• You need to use supplemental oxygen at home
• You are infected with HIV, hepatitis B, or hepatitis C
• You have another serious uncontrolled illness, such as an uncontrolled infection, heart failure, unstable chest pain, irregular heart rhythm, or a mental health or personal situation that could affect your ability to participate
• You have been diagnosed with another cancer or a blood/bone marrow disorder in the past 5 years (some exceptions may apply — confirm with trial site)
• You have had surgery within 28 days before starting the study drug (minor procedures such as dental work or skin biopsy may be exceptions — confirm with trial site)
• You have received a live vaccine for an infectious disease (such as flu or shingles) within 28 days before starting study treatment
• You currently use illegal drugs or misuse substances including alcohol in a way that could affect your ability to follow the study requirements
• You are unwilling or unable to follow the study schedule for any reason
• You are pregnant or currently breastfeeding
• You have fluid buildup around your lungs or in your abdomen that shows on a scan or causes symptoms
• You have a history of a serious blockage in your small intestine related to cancer
• You are currently receiving nutrition through an intravenous (IV) line rather than eating normally
• You are known or suspected to be allergic to a substance called Hiltonol (an ingredient used in the study)
• Your doctor determines there is any other medical, mental health, or personal reason that makes participation unsuitable

Important: Always verify eligibility with the trial site directly before applying.