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 able to give voluntary, informed consent and are willing to follow all study procedures from start to finish.
• People aged 18 or older (or the adult age as defined by local rules).
• People with a cancer diagnosis confirmed by tissue or cell testing, where the cancer is advanced, cannot be surgically removed, or has spread, and has stopped responding to standard treatments — or where no standard treatment exists. (Note: In one part of the trial called Phase 2b, only people with advanced colorectal cancer who are eligible to receive a chemotherapy regimen called FOLFOX will be enrolled.)
• People whose cancer has at least one measurable area of disease, as defined by standard imaging guidelines (RECIST v1.1), in a location that has not previously been treated with radiation or local therapy — unless clear imaging evidence shows the cancer has grown back in that area since treatment.
• People whose doctor estimates they have a life expectancy of at least 3 months.
• People with a good general level of physical functioning, rated 0 or 1 on a standard scale used in cancer trials (meaning fully active or restricted in strenuous activity but able to carry out light work).
• People whose blood counts, liver function, and kidney function meet the required levels, specifically: sufficient white blood cells, haemoglobin, and platelets without recent medical support; liver enzyme and bilirubin levels within acceptable ranges; and kidney function above a certain threshold based on a standard calculation. These must be met without recent transfusions, growth factors, or other supportive medications.
• People with normal blood clotting test results, or for those taking blood thinners, results within an acceptable range as determined by the trial doctor.
• People of childbearing potential (both male and female) who are willing to use effective contraception from the screening visit, throughout the study, and for at least 3 months after the last dose of the study drug. Female participants who are postmenopausal must have had no periods for at least 12 months, confirmed by hormone testing if needed. Male participants must agree not to donate sperm for at least 3 months after the last dose.

Who may not be able to join:

• People who are currently receiving other cancer treatments at the same time (such as chemotherapy, targeted therapy, radiation, hormonal therapy, or certain traditional medicines) — except that in Phase 2b, FOLFOX-based chemotherapy for colorectal cancer is permitted.
• People who have recently used another experimental drug or medical device — within 5 half-lives of a small-molecule experimental drug, or within 2 weeks for an experimental medical device, before the first dose of the study drug. Prior use of an experimental antibody treatment may be considered with sponsor approval.
• People with serious or uncontrolled illness, active infection, or abnormal test results that the trial doctor considers would make participation unsafe or unsuitable.
• People who are pregnant, currently breastfeeding, or planning to become pregnant (or whose partner is planning to become pregnant) at any point during the study or follow-up period.
• People who have had major surgery or a serious injury within 4 weeks before starting the study drug, who have not fully recovered from major surgery, or who are likely to need major surgery during the study.
• People who have an abnormal heart electrical reading (specifically, a prolonged QTcF interval above 470 ms on an ECG), a history of certain heart rhythm risk factors (such as heart failure, low potassium, or a family history of a condition called long-QT syndrome), or who are taking medications known to affect this heart measurement.
• People with psychiatric, psychological, personal, or location-related circumstances that, in the trial doctor's judgement, could interfere with treatment, follow-up, or compliance, or could put the person at high risk of complications.
• People who have donated blood or experienced significant blood loss within the 60 days before the first dose of the study drug.
• People with a history of severe allergic reactions, including anaphylaxis, or known sensitivity to the study drug or any of its ingredients.
• People who have received a live vaccine within 4 weeks before the first dose of the study drug.
• People who have recently taken medications that significantly suppress the immune system (including experimental therapies) within 5 half-lives of those products before the first dose, and these medications would not be permitted during the study.
• People who have recently taken certain specific medications that are broken down mainly by a particular liver enzyme (CYP2C8) and have a narrow safe dosing range, within 5 half-lives before the first dose. These medications would not be permitted during the study.
• People who use stomach acid-reducing medications in the window between 6 hours before and 2 hours after taking the study drug.
• People who test positive for Hepatitis C antibodies, Hepatitis B surface antigen, or HIV (HIV-1 or HIV-2) at the screening visit — unless they meet specific exceptions: people with chronic but well-controlled Hepatitis B who have been on appropriate antiviral treatment for at least 4 weeks, or people who have previously had Hepatitis C and completed curative treatment with no detectable virus remaining. (Confirm with trial site, as these cases are reviewed individually.)
• People whose participation the trial doctor considers would pose a safety risk, prevent full participation, or affect the reliability of the study results.

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