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 have given written consent and are willing and able to follow the trial's required visits and procedures.
• People who have been confirmed by laboratory testing to have pancreatic adenocarcinoma (a specific type of pancreatic cancer) that cannot be surgically removed and has either spread locally, come back, or spread to other parts of the body.
• People whose cancer cannot be treated with the aim of a cure (such as major surgery or high-dose radiotherapy), and — for those who previously had chemotherapy or radiation as part of earlier treatment — whose cancer returned or spread more than 6 months after that treatment ended.
• People who have at least one measurable area of cancer that has not previously been treated with radiotherapy, as confirmed by CT or MRI scan (confirm with trial site for exact size requirements).
• People aged 18 or older, of any gender.
• People whose general physical fitness is rated 0 or 1 on the ECOG scale, meaning they are fully active or have only mild limitations in physical activity.
• People with an estimated life expectancy of at least 12 weeks.
• People with adequate bone marrow and organ function (confirm with trial site for specific blood test thresholds).
• Women of childbearing age, or men whose partner could become pregnant, who are willing to use effective contraception throughout treatment and for 6 months after treatment ends.
• People whose tumour tissue has tested positive for a protein called CLDN18.2.
• For the first part of the trial: people with locally advanced or recurrent/metastatic pancreatic cancer, with or without prior systemic treatments such as chemotherapy or immunotherapy.
• For the second part of the trial: people with locally advanced or recurrent/metastatic pancreatic cancer who have not yet received any systemic treatments such as chemotherapy, targeted therapy, or immunotherapy.

Who may not be able to join:

• People currently taking part in another interventional clinical trial (participation in non-interventional or observational studies, or being in a survival follow-up phase of a previous trial, may be acceptable — confirm with trial site).
• People who have taken a strong CYP3A4 inhibitor (a type of medication that affects how the body processes certain drugs) within 2 weeks or 5 half-lives before the first dose, whichever is longer (confirm with trial site for specific medications).
• People who received anti-cancer treatment within 4 weeks or 5 half-lives before the first dose, whichever is shorter.
• People who received radiotherapy for treatment or symptom relief within 2 weeks before the first dose.
• People who had a biliary stent placed or a bile drainage procedure (PTCD) within 7 days before the first dose.
• People who are planning to receive other cancer treatments during the trial, apart from limited palliative radiotherapy for symptom relief that does not affect the trial's results.
• People who received a live vaccine within 4 weeks before the first dose, or who plan to receive one during the trial.
• People who had major surgery within 4 weeks before the first dose, or who have wounds, ulcers, or fractures that have not healed, or who plan to have major surgery during the trial (minor local surgery for palliative purposes may be acceptable — confirm with trial site).
• People who have not yet recovered from significant side effects of previous treatments before starting the trial (certain exceptions such as hair loss or fatigue may apply — confirm with trial site).
• People who have had a hole or abnormal connection in the gastrointestinal tract (perforation or fistula) within the past 6 months that was not resolved by surgery, or who have a blocked stomach outlet or ongoing repeated vomiting.
• People who have had a stent placed in the gastrointestinal tract or airway.
• People with brain or central nervous system (CNS) metastases that are causing symptoms; people with small, stable, asymptomatic brain metastases may be considered under specific conditions (confirm with trial site).
• People with bone metastases that put them at risk of spinal cord injury leading to paralysis.
• People with lung conditions such as interstitial lung disease, pulmonary fibrosis, severe radiation-related lung damage, or acute lung injury, particularly if requiring steroid treatment.
• People with other uncontrolled diseases or a history of another primary cancer (confirm with trial site).
• People with a known history of immune deficiency.
• People who have had an organ transplant or bone marrow/stem cell transplant from a donor.
• People who have previously been treated with a specific type of drug called an antibody-drug conjugate based on topoisomerase inhibitors.
• People with a known allergy to the study drugs or their ingredients.
• People for whom the study drugs are medically contraindicated.
• People with a history of serious non-infectious reactions to the study drugs (confirm with trial site for clarification).
• Women who are pregnant or breastfeeding.
• People who the trial investigators determine are not suitable for other reasons.

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