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 who have been diagnosed with localised pancreatic adenocarcinoma (a specific type of pancreatic cancer) through laboratory testing, where a specialist team has determined the cancer can be surgically removed, and who have not received any prior treatment for this cancer.
• People whose tumour tests positive for a protein called claudin 18.2 (CLDN18.2), confirmed by a laboratory before the first dose of the study drug (confirm with trial site if results are still pending or a biopsy is not possible).
• People who have a pre-treatment tumour tissue sample available, where clinically appropriate and where the sample meets the study's requirements.
• People who are medically able to have surgery and to receive standard follow-up chemotherapy after surgery.
• People with a known heart condition or history of treatment with heart-affecting medicines, where a doctor has assessed their heart function as being at a level called "Class 2B or better" using a standard heart health scale.
• Women who are not pregnant, and who are either unable to become pregnant, or who test negative for pregnancy at the start of the study and agree to use reliable contraception for at least 6 months after the final dose of the study drug (or longer if required by the chemotherapy guidelines).
• Women who agree not to breastfeed or donate eggs from the start of the study until at least 6 months after the final dose of the study drug (or longer if required by the chemotherapy guidelines).
• Men who agree to use contraception with any female partner who could become pregnant, and to use a condom with any pregnant partner, from the start of treatment until at least 6 months after the final dose of the study drug (or longer if required by the chemotherapy guidelines).
• Men who agree not to donate sperm during the treatment period and for at least 6 months after the final dose of the study drug (or longer if required by the chemotherapy guidelines).
• People who have at least one tumour that can be measured using standard imaging methods, assessed within 28 days before the first dose of the study drug.
• People who are in good enough general health to carry out everyday activities with no more than minor limitations, based on a standard medical rating scale (ECOG score of 0 or 1).
• People whose heart electrical activity, measured by a specific calculation from an ECG, falls within an acceptable range (QTcF of 470 milliseconds or less).
• People whose blood test results, taken within 7 days before the first dose, show that their organs and bone marrow are functioning adequately (any blood transfusion must have occurred at least one week before these tests).
• People who agree not to take part in any other treatment-based clinical study at the same time as this one.

Who may not be able to join:

• People who have had unstable chest pain, a heart attack, a serious irregular heartbeat, or a hospitalisation for heart failure within the 6 months before the first dose of the study drug.
• People who have an active infection requiring treatment with medicines that has not fully cleared up within 7 days before starting the study.
• People who have an active autoimmune disease (where the immune system attacks the body) that has required immune-suppressing medication within the past month before starting the study.
• People with serious uncontrolled mental health conditions or personal circumstances that would make it difficult to follow the study requirements.
• People who have another type of cancer that currently requires treatment.
• People who have a history of, or complications from, a lung condition called interstitial lung disease (scarring or inflammation of the lungs).
• People who have a complete or partial blockage of the stomach outlet that is causing ongoing or repeated vomiting.
• People who are known to have a genetic condition called DPD deficiency, which affects how certain chemotherapy medicines are broken down in the body — this applies where the study chemotherapy includes a type of drug called a fluoropyrimidine (confirm with trial site regarding local screening requirements).
• People who have an uncontrolled blood clotting problem, or who are taking a full dose of the blood thinner warfarin (Coumadin) — note that certain other blood-thinning medicines such as low molecular weight heparin or direct oral anticoagulants may be permitted.
• People who have a history of abnormal bleeding or who have had a significant bleeding event (graded as Grade 2 or higher) in the month before treatment.
• People who have an uncontrolled ongoing illness or infection.
• People known to have HIV infection, unless their immune cell counts are at an acceptable level and they have had no serious HIV-related infections in the past 6 months (confirm with trial site regarding local testing requirements).
• People known to have active hepatitis B or hepatitis C infection — certain exceptions may apply depending on specific test results (confirm with trial site regarding local testing requirements).
• People with a specific inherited gene variation affecting the UGT1A1 gene that completely removes a particular enzyme's function — this applies where the study chemotherapy includes a medicine called irinotecan.
• People who have a serious pre-existing stomach condition such as active gastritis or a stomach ulcer that could be made worse by treatment.
• People who have previously received any chemotherapy, radiation, immunotherapy, targeted therapy, or experimental treatment for their pancreatic cancer.
• People who have received a live vaccine within 30 days before the planned start of the study — note that standard inactivated flu injections are generally permitted.
• People who have any other significant health condition or circumstance that a doctor believes could make participation unsafe or unsuitable.
• People who have had a serious allergic reaction, known sensitivity, intolerance, or a medical reason not to receive any of the study medicines.
• People who have had a major surgical procedure within 28 days before starting the study and have not fully recovered.

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