Phase 2 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 are willing to give written consent and are able to follow the trial schedule and procedures.
• People who have been confirmed by tissue testing to have pancreatic cancer that cannot be surgically removed, has come back, or has spread to other parts of the body.
• People whose cancer got worse during, or who could not tolerate, a first round of chemotherapy that included a drug called gemcitabine (or whose cancer came back within 6 months of finishing earlier chemotherapy, which counts as first-line treatment).
• People whose cancer is not suitable for treatments aimed at a cure, such as intensive radiation therapy combined with chemotherapy or surgery.
• People who have at least one tumour that can be measured on a scan (CT or MRI) that has not previously been treated with radiation (confirm with trial site for exact measurement details).
• People aged 18 or older; any gender is eligible.
• People with a good general health and activity level, as measured by a standard scale called ECOG, with a score of 0 or 1 (meaning fully active or restricted only in physically demanding activity).
• People with a Body Mass Index (BMI) of at least 17 kg/m².
• People with a life expectancy of at least 12 weeks.
• People whose bone marrow, liver, kidneys, and blood clotting are functioning well enough to meet specific laboratory test thresholds (confirm with trial site for exact values).
• People who are able and willing to use effective contraception throughout treatment and for 6 months after treatment ends — this applies to women who could become pregnant, and to men whose partners could become pregnant.
• People whose tumour tissue has tested positive for a specific protein called CLDN18.2 (Claudin 18.2), confirmed by laboratory testing (people who have previously received treatment targeting this protein must have a new tumour sample taken after that treatment ended).

Who may not be able to join:

• People who are currently taking part in another clinical trial that involves a treatment or intervention (participation in observation-only studies or survival follow-up is generally acceptable).
• People who have taken certain medications that affect a liver enzyme called CYP3A4 within 2 weeks or 5 half-lives of starting the trial drug, whichever is longer.
• People who received any anti-cancer treatment within 4 weeks or 5 half-lives of starting the trial drug, whichever is shorter.
• People who received radiation therapy for treatment or symptom relief within 2 weeks before starting the trial drug.
• People who had a bile duct stent placed or a bile drainage procedure (PTCD) within 7 days before starting the trial drug.
• People who plan to receive other anti-cancer treatments during the trial (limited symptom-relief radiation may be allowed — confirm with trial site).
• People who received a live vaccine within 4 weeks before starting the trial drug, or who plan to receive one during the trial.
• People who had major surgery within 4 weeks before starting the trial drug, or who have wounds, ulcers, or fractures that have not healed, or who plan to need major surgery during the trial (minor local procedures for symptom relief may be acceptable — confirm with trial site).
• People who still have significant side effects from previous cancer treatments that have not recovered to an acceptable level (hair loss and certain other minor effects may be exceptions — confirm with trial site).
• People who had a hole or abnormal opening in the digestive tract (perforation or fistula) in the 6 months before starting the trial that was not fully treated with surgery.
• People who have a blockage in the stomach outlet (pyloric obstruction) or who are vomiting frequently (3 or more times within 24 hours).
• People who have had a stent placed in the digestive tract or airway.
• People who have brain or central nervous system (CNS) metastases causing symptoms; people with small, stable, symptom-free brain metastases may be considered under specific conditions (confirm with trial site for detailed requirements).
• People who have bone metastases that put them at risk of spinal cord injury.
• People who have lung disease such as interstitial lung disease, severe radiation damage to the lungs, pulmonary fibrosis, or other serious uncontrolled lung conditions, or who required steroid treatment for lung inflammation.
• People with poorly controlled infections requiring ongoing antibiotic, antiviral, or antifungal treatment in the week before starting the trial drug.
• People who are HIV positive.
• People with active hepatitis B or hepatitis C infection above certain viral levels (people whose levels are controlled with antiviral treatment, or who test negative for active virus, may be considered — confirm with trial site).
• People with active tuberculosis, or who are being treated for tuberculosis, or who were treated for tuberculosis within the past year.
• People with active or latent syphilis requiring treatment.
• People with significant heart problems, including moderate-to-severe heart failure, poorly controlled irregular heartbeat, a prolonged electrical signal in the heart (QTc interval of 480ms or more), or a personal or family history of inherited heart rhythm conditions.
• People with high blood pressure that is not well controlled (systolic blood pressure of 160 mmHg or higher, or diastolic blood pressure of 100 mmHg or higher) despite treatment.
• People considered to be at risk of developing an abnormal connection between the digestive and respiratory tracts (fistula).
• People with fluid build-up around the lungs, in the abdomen, or around the heart that is causing symptoms and needs to be drained.
• People with swollen veins in the oesophagus or stomach that need urgent treatment or are considered at high risk of bleeding (confirm with trial site for endoscopy requirements).
• People who had a serious bleeding event or a significant bleed from the digestive tract or varicose veins requiring transfusion, endoscopy, or surgery in the 3 months before starting the trial drug.
• People who had a serious blood clot in an artery — such as a heart attack, stroke, or mini-stroke — within 6 months before starting the trial drug.
• People who had a new or unstable blood clot in a deep vein or the lungs within 3 months before starting the trial drug (certain types of clots related to IV lines may be excepted — confirm with trial site).
• People with serious liver conditions including brain problems caused by liver disease (hepatic encephalopathy), liver-related kidney failure, or a liver disease severity score (Child-Pugh) above 7.
• People with a risk of bowel blockage or perforation, or who have conditions such as Crohn's disease, ulcerative colitis, a history of abdominal abscess, or who have had large portions of their bowel removed.
• People with other medical conditions, abnormal test results, or mental health, neurological, or social circumstances that the trial doctor considers would make participation unsafe or unsuitable.
• People with a history of another type of cancer, unless it was successfully treated at least 2 years ago with very low risk of return, or was a type of skin cancer or pre-cancerous condition that was fully treated with no signs of return.
• People with a known history of immune system deficiency.
• People who have previously received an organ transplant or bone marrow/stem cell transplant from a donor.
• People who have previously received a type of cancer treatment called an antibody-drug conjugate (ADC) that works by targeting an enzyme called topoisomerase.
• People with a known allergy to any of the drugs used in this trial.
• People who have a medical reason that makes taking the trial drugs unsafe (contraindication — confirm with trial site).
• People who previously had to permanently stop taking any of the trial drugs due to a serious drug-related reaction.
• People who are pregnant or breastfeeding.
• People whom the trial doctor considers ineligible for any other reason.

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