Early 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:

• People aged 18 or older, of any gender
• People who have a tumor tissue sample available — either recently collected or stored within the past 5 years — that can be tested during the screening process
• People who have been diagnosed with an advanced solid tumor (confirmed through laboratory analysis of tissue or cell samples) where standard treatments are no longer working, do not exist, or have been assessed by the doctor as not suitable — tumor types include but are not limited to pancreatic cancer, colorectal cancer, non-small cell lung cancer, bile duct cancer, gallbladder cancer, ovarian cancer, endometrial cancer, and intestinal cancer
• People whose tumor has a specific genetic change called a RAS G12V mutation (in KRAS, NRAS, or HRAS), and who also carry one of four specific immune system markers (HLA-DPB1*03:01, *14:01, *25:01, or *104:01) — these would be identified through testing
• People who have at least one measurable tumor in their body, as defined by standard measurement guidelines (confirm with trial site)
• People with a general health and activity level scored at 0 or 1 on a standard medical scale, meaning they are either fully active or have minor restrictions but are able to carry out light activity (confirm with trial site)
• People whose doctors expect them to live for more than 3 months
• People whose blood counts, liver, kidney, and heart function all meet specific minimum levels as measured by laboratory tests — the trial site will assess this during screening
• Women who are able to become pregnant, who agree to use at least one reliable method of contraception throughout the study and for one year after the last treatment, and who have a negative pregnancy test at screening
• People whose side effects from any previous cancer treatment have mostly resolved — specifically to a mild level or lower — by the time of screening (with some exceptions such as hair loss or mild thyroid issues, which are allowed)
• People who have read and understood the informed consent information, agree to take part, and are willing to sign the consent form

Who may not be able to join:

• People who have had a different type of cancer (other than the ones being studied in this trial) within the past 5 years — exceptions include fully treated thyroid cancer, a common type of skin cancer (basal cell carcinoma), or early-stage cervical cancer that has been cured
• People whose cancer has spread to the membranes around the brain or spinal cord
• People whose cancer has spread to the brain, unless the brain metastases have been fully treated with radiotherapy or surgery, have been stable on scans for at least 4 weeks, and the person has been off steroid medications for more than 2 weeks and has no symptoms
• People who have received a previous treatment specifically targeting the RAS-G12V mutation within 4 weeks before starting the trial (or within 5 half-lives of that drug, whichever is longer)
• People who are currently taking part in another clinical trial involving an experimental treatment within 4 weeks before starting this trial
• People who have received systemic cancer treatments (such as chemotherapy, radiotherapy, immunotherapy, or cell therapy) within 4 weeks or 5 half-lives — whichever is shorter — before starting the trial
• People who have had major surgery within 4 weeks before starting the trial and have not fully recovered, or who are planning major surgery during the study
• People who have taken immune-suppressing medications or steroid medications (taken throughout the body, not just applied to skin) within 1 week before starting the trial
• People who have received a live vaccine within 4 weeks before starting the trial, or who plan to receive one during the study
• People who plan to receive any other systemic cancer treatment during the study
• People who have fluid build-up in the abdomen, around the lungs, or around the heart that requires draining at screening, or who had such fluid drained within 4 weeks before starting the trial
• People who have had significant heart problems in the 6 months before joining, including heart failure, unstable chest pain, a heart attack, stroke or mini-stroke, certain serious heart rhythm problems, or blood pressure that is not well controlled
• People whose heart's electrical activity (measured by an ECG) shows a specific abnormality in a measurement called QTcF of 470 milliseconds or more
• People who have had a serious infection within 4 weeks before starting the trial, or who currently need intravenous (IV) antibiotics for an active infection within 2 weeks before starting the trial
• People who have an active autoimmune disease, or who need steroid or immune-suppressing medications at the time of screening (above a certain dose level)
• People who have other serious ongoing health conditions that are unstable or poorly controlled, such as heart, lung, kidney, liver, metabolic, or blood disorders
• People with a known severe allergy or sensitivity to the trial treatment or any of its ingredients
• People who have had an organ transplant, a stem cell transplant using donor cells, or who are currently on dialysis or another form of kidney replacement therapy
• People who have a history of, or currently have, a blood clot in the lungs, lung scarring (pulmonary fibrosis), inflammatory lung disease, or acute lung disease
• People who test positive for syphilis antibodies, HIV antibodies, or who have an active hepatitis B or hepatitis C infection at screening
• People whom the trial doctor considers unsuitable for any other reason

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