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 aged 18 or older
• People who have been diagnosed with either locally advanced (cannot be surgically removed) or metastatic non-small cell lung cancer (NSCLC) or pancreatic cancer (PDAC), confirmed by tissue testing, and whose cancer has a specific gene change called KRAS G12D, found in a recent tumour sample or blood test
• People with NSCLC who have no known targetable gene changes (or have one for which no approved targeted treatment is available to them) and have already received at least one prior treatment including a platinum-based chemotherapy and an immunotherapy drug, and whose cancer has since worsened
• People with NSCLC who have a known actionable gene change (such as EGFR, BRAF, MET, ALK, ROS1, RET, or NTRK) and have already used all available targeted treatments, as well as a platinum-based chemotherapy, and whose cancer has since worsened
• People with pancreatic cancer who have received exactly one prior chemotherapy treatment for at least 5 months and whose cancer has since worsened
• People who are in good enough general health to be independently active for most of the day, as measured by a standard medical scale (ECOG performance status of 0 or 1)
• People who are expected to live for at least 3 more months
• People who have at least one tumour that can be measured on a scan, according to standard criteria (RECIST v1.1)
• People who have a tumour site that can be safely biopsied, and who agree to provide tumour and blood samples before, during, and at the end of treatment
• People whose blood counts and organ function (bone marrow, kidneys, liver, and blood clotting) meet specific minimum levels based on lab tests taken within 21 days before starting the trial
• People with a blood oxygen level above 93% while breathing normal room air
• Women who could become pregnant must have a negative pregnancy test at the start of the trial and agree to use highly effective contraception during the trial and for at least 6 months after the last dose of the study drug
• Women who could become pregnant must agree not to donate or collect eggs for personal use from the start of the trial until at least 6 months after the last dose
• Men must either be surgically sterile, abstain from heterosexual intercourse, or use highly effective contraception during the trial and for at least 3 months after the last dose of the study drug
• Men must agree not to freeze or donate sperm from the start of the trial until at least 3 months after the last dose
• People who are willing and able to understand, sign, and date a consent form before any trial procedures begin, and who are able to follow the trial schedule
• People who are covered by a social security or health insurance system (as required under French regulations)

Who may not be able to join:

• People who are unwilling to have blood or tumour tissue samples collected as required by the trial
• People whose NSCLC or pancreatic cancer could potentially be treated with the aim of a cure
• People who have had a serious allergic reaction to the study drug or any of its ingredients in the past
• People who have not waited long enough since their last treatment before starting the trial — including recent whole-brain or stereotactic brain radiotherapy (within 14 days), wide-field or bone marrow radiotherapy (within 28 days), palliative radiotherapy (within 7 days), other cancer drugs or immunotherapy (within 21 days or 5 half-lives, whichever is shorter), major surgery (within 28 days), live vaccines (within 28 days), or systemic steroid or immunosuppressant therapy (within 7 days)
• People who have previously been treated with a drug that specifically targets the KRAS G12D mutation, or a drug targeting the broader RAS protein family in a way that includes KRAS G12D
• People with active or untreated cancer spread to the brain, or with spinal cord compression that is causing symptoms or requiring treatment with steroids or anti-seizure medication — however, people with treated and stable brain metastases that are not causing symptoms and do not require such medications, and who have been neurologically stable for at least 28 days, may be considered (confirm with trial site)
• People with cancer spread to the lining of the brain or spinal cord (leptomeningeal disease)
• People who still have unresolved side effects from previous cancer treatments that have not returned to mild or baseline levels (except hair loss)
• People who have had another type of cancer within the past 2 years, with some exceptions such as adequately removed non-melanoma skin cancer or cancers that have been fully treated and cured
• People with serious uncontrolled medical conditions, including active bleeding disorders, active infections, severe psychiatric illness, substance misuse, or other conditions that the treating doctor considers would make participation unsafe or difficult
• People who needed intravenous antibiotics for an active infection within the 14 days before starting the trial
• People with significant fluid build-up around the lungs, or fluid in the abdomen that has required medical treatment within 30 days before signing the consent form
• People with significant or uncontrolled heart problems, including abnormal heart rhythm readings on an ECG, reduced heart pumping function, heart attack or unstable chest pain within the past 6 months, significant heart failure, or significant fluid around the heart
• People with active hepatitis B or active hepatitis C infection
• People diagnosed with HIV, unless they are on antiviral therapy with an undetectable viral load and willing to undergo regular monitoring throughout the trial
• Women who are pregnant, breastfeeding, or planning to become pregnant during the trial or within 6 months after the last dose of the study drug
• People with psychological, personal, social, or geographical circumstances that may make it difficult to follow the trial schedule and requirements
• People who are under legal guardianship, court protection, or who are unable to give their own consent
• People who need to take strong inhibitor or inducer medications that significantly affect how the body processes certain drugs (specifically CYP3A or CYP2D6 pathways)
• People who need to take certain other medications that are processed through a specific liver pathway (CYP2C8 sensitive substrates) (confirm with trial site)
• People currently participating in another clinical trial testing an experimental drug, or who have done so within 30 days or 5 half-lives (whichever is longer) before joining this trial

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