Phase 2 Pancreatic Cancer Trial, Recruiting

Written by an AI model from the 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 between 18 and 75 years old (inclusive).
• People with metastatic pancreatic cancer (cancer that has spread from the pancreatic ducts to other parts of the body) for one group (Arm A), or locally advanced pancreatic cancer (cancer that has grown but not spread far from the pancreas) for another group (Arm B).
• People whose tumour has a specific gene change called KRAS G12D mutation.
• People who have not received any systemic (whole-body) cancer treatments for their advanced cancer; or, if previous pre- or post-surgery cancer treatment was given, the last dose must have been more than 6 months ago.
• People who have at least one tumour that can be measured using standard imaging guidelines (RECIST v1.1).
• People who are relatively well and active — rated 0 or 1 on a standard health performance scale (ECOG score), meaning fully active or able to carry out light activity.
• People who are expected to survive for at least 3 months.
• People whose blood counts and organ function meet specific requirements, including: sufficient white blood cells, platelets, and haemoglobin levels; adequate liver, kidney, and heart function; acceptable protein levels in blood and urine; and a normal heart rhythm measurement (confirm with trial site for exact values).
• Women of childbearing age must have a negative blood pregnancy test within 7 days before joining, must not be breastfeeding, and must agree to use appropriate contraception during the trial and for 6 months after treatment ends.
• Men must either have had a surgical sterilisation procedure or agree to use appropriate contraception during the study and for 6 months after treatment ends.
• People who are willing to volunteer, sign a consent form, follow the study requirements, and attend follow-up appointments.

Who may not be able to join:

• People who have previously received a treatment that specifically targets the KRAS G12D mutation.
• People who have previously received a treatment that specifically targets EGFR.
• People who had major surgery or a serious physical injury within the 4 weeks before joining, or who received local treatments such as palliative radiotherapy or interventional procedures within the 2 weeks before joining.
• People who have taken part in another clinical trial involving an experimental treatment within the 4 weeks before joining (observational studies without treatment are generally acceptable — confirm with trial site).
• People who have taken certain medications that strongly affect how the liver processes drugs (specifically CYP3A4 or CYP2C8 inhibitors or inducers) in the 14 days before joining.
• People who have cancer that has spread to the brain or central nervous system.
• People with acute or chronic inflammation of the pancreas (pancreatitis) that requires medical treatment.
• People who have had symptoms of a blocked bowel within the 6 months before starting the study, unless surgery was performed and the blockage was completely resolved.
• People who have a significant build-up of fluid in body cavities (such as the chest or abdomen) that is not stable within 2 weeks before joining; small amounts of fluid seen on scans without symptoms may be acceptable (confirm with trial site).
• People who had a serious infection (such as severe pneumonia or a bloodstream infection requiring hospitalisation) within 4 weeks before joining, or an unexplained fever above 38.5°C within 2 weeks before joining.
• People with serious heart or blood vessel disease.
• People with known or suspected lung inflammation (interstitial pneumonia), except where only minor imaging changes are present with no other signs.
• People with a known history of significant neurological or psychiatric conditions, including epilepsy or dementia.
• People with wounds that are not healing, or fractures that have not been treated.
• People who still have significant side effects from previous cancer treatments that have not recovered to a mild level (with some exceptions — confirm with trial site).
• People who have had another cancer in the past 5 years, except for certain low-risk cancers such as treated cervical carcinoma in situ, or certain skin cancers.
• People with active Hepatitis B, active Hepatitis C, HIV, active syphilis, or active tuberculosis (or a history of active tuberculosis within the past 48 weeks).
• People with a known allergy to any of the study drugs or their components, including HRS-4642, nytuzumab, albumin-bound paclitaxel, or gemcitabine.
• People who, in the opinion of the trial doctor, have any other condition that could affect the study results or their safety.

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