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 whose tumour testing (using a method called NGS) has confirmed a specific gene deletion called "homozygous MTAP deletion," detected from tissue collected within the past 6 months or from a blood sample.
• People with a confirmed diagnosis of pancreatic ductal adenocarcinoma (a specific type of pancreatic cancer), confirmed through laboratory analysis of a tissue or cell sample.
• People who are generally well enough to carry out light activity and care for themselves, as measured by a standard medical fitness scale (ECOG score of 0 or 1).
• People whose blood counts and organ function meet the required levels — including red blood cells, white blood cells, platelets, liver enzymes, bilirubin, and kidney function — without having needed a blood or platelet transfusion in the past 7 days (confirm specific values with trial site).
• People who are willing to follow the study schedule, including treatment visits and examinations, for the full duration of the trial.
• People who are able to understand the study and are willing to sign a consent form agreeing to participate.
• Women who could become pregnant must agree to use a highly effective combination of contraceptive methods (hormonal plus non-hormonal, or a non-hormonal method alone) during the treatment period and for at least 9 months after the last dose, or longer if required for individual medicines used in the study — and must agree not to donate eggs during this period.
• Men must agree to use a condom during any sexual activity with a woman who could become pregnant, throughout treatment and for at least 6 months after the last dose, or longer if required for individual medicines used in the study — even if they have had a vasectomy — and must agree not to donate sperm during this period.

For Cohort 1 only (surgery may be possible):

• People with pancreatic cancer that is considered removable by surgery, or borderline removable, based on how much the tumour has grown into nearby blood vessels, and who have not yet received any treatment before surgery (confirm tumour classification details with trial site).

For Cohort 2 only (cancer has grown locally but has not spread to distant parts of the body):

• People with locally advanced pancreatic cancer that cannot be surgically removed, based on how much the tumour has grown into nearby major blood vessels (confirm specific criteria with trial site).
• People who have received no prior treatment, except for up to one month of a chemotherapy combination called gemcitabine/nab-paclitaxel (GA), provided the cancer has not worsened during that time.

For Cohort 3 only (cancer has spread to other parts of the body):

• People with pancreatic cancer that has spread (metastatic).
• People who have received no prior treatment, except for up to one month of a chemotherapy combination called mFOLFIRINOX, provided the cancer has not worsened during that time.

Who may not be able to join:

• People who have previously been treated with a type of drug called a PRMT5 or MAT2A inhibitor.
• People who have taken part in another clinical trial or received an experimental treatment within the past 30 days, or within 5 half-lives of that drug — whichever is longer.
• People with another active or recent cancer diagnosis, except for certain treated cancers with no signs of return for at least 2 years, or specific low-risk cancers such as some skin cancers, early-stage cervical cancer, or early-stage breast or endometrial cancer (confirm details with trial site).
• People who have had major surgery within 2 weeks before starting treatment, or who have not yet recovered from a recent surgery.
• People who have needed fluid drained from the abdomen or chest cavity within the past month.
• People with certain heart problems, including reduced heart pumping function, a history of abnormal heart rhythm measurements, or serious heart events in the past 6 months such as heart attack, stroke, heart failure, or irregular heartbeat (confirm specific conditions with trial site).
• People who need to take certain medications that can affect heart rhythm or interfere with how the study drugs are processed by the body, and for whom switching to an alternative is not possible before joining (confirm specific drug categories with trial site).
• People with active hepatitis B or hepatitis C infection showing signs of active virus in the blood (people with evidence of past vaccination or resolved infection may still be eligible — confirm with trial site).
• People with HIV who have had a serious HIV-related infection in the past year, or whose immune cell count is below a certain level, or who have not been on stable HIV treatment for at least 4 weeks before joining (confirm details with trial site).
• People with an active infection currently being treated with antibiotics, antiviral, or antifungal medicines within 7 days before the first dose.
• People who have received a live or weakened (attenuated) vaccine within 30 days before starting treatment (standard inactivated flu vaccines are permitted).
• People who have used herbal supplements or traditional plant-based medicines intended to treat their cancer within the past 4 weeks, or who would need to continue using them during the study.
• People who have previously received an organ transplant from a donor.
• People with a known allergy to the study drug or any of its ingredients.
• People with cancer that has spread to the brain or the lining of the brain or spinal cord, unless that spread has been fully treated and no steroids or anti-seizure medicines are currently needed.
• People who are unable to swallow tablets or capsules, or who have gut problems that a treating doctor believes would prevent the study drug from being properly absorbed.
• People who are pregnant or breastfeeding.
• People with a history of certain lung conditions, including interstitial lung disease, pulmonary fibrosis, sarcoidosis, silicosis, or severe allergic lung reactions.

For Cohort 1 only:

• People whose cancer has spread to distant parts of the body, or whose cancer is locally advanced and cannot be surgically removed.
• People whose medical team determines that radiation therapy before surgery will be needed.

For Cohort 2 only:

• People whose cancer has spread to distant parts of the body.
• People who have received chemotherapy or targeted therapy within 28 days of starting the study, or radiation therapy within 14 days of starting the study.
• People who have already received more than one course of prior cancer treatment.
• People with ongoing significant side effects (grade 2 or higher on a standard medical scale) from a previous cancer treatment, except for hair loss or grade 2 nerve-related symptoms.

For Cohort 3 only:

• People who have received chemotherapy or targeted therapy within 28 days of starting the study, or radiation therapy within 14 days of starting the study.
• People who have already received more than one course of prior cancer treatment.
• People with ongoing significant side effects (grade 2 or higher on a standard medical scale) from a previous cancer treatment, except for hair loss or grade 2 nerve-related symptoms.

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