Phase 1 Mesothelioma 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 been diagnosed with one of three specific cancers, confirmed by a pathologist: diffuse pleural mesothelioma (a cancer of the lining around the lungs), gastroesophageal carcinoma (cancer of the esophagus, the junction between the esophagus and stomach, or the stomach itself, with specific protein marker requirements), or urothelial carcinoma (cancer of the bladder or urinary tract).
• People whose cancer has spread or cannot be removed by surgery.
• People with gastroesophageal or mesothelioma cancer who have not previously received systemic treatment (such as chemotherapy) for their metastatic disease, with some exceptions allowed with the lead doctor's approval.
• People with urothelial carcinoma who have received at least one prior treatment, but not gemcitabine (a chemotherapy drug), unless it was given before surgery at least 12 months before joining the trial.
• People whose tumor tissue has been tested and shows a specific genetic change called MTAP deletion, confirmed by either a protein stain (IHC) test or a genetic (NGS) test done on tumor tissue.
• People whose cancer can be measured on scans according to standard guidelines (RECIST v1.1, or modified RECIST for mesothelioma).
• People who have no medical reason preventing them from receiving the standard treatments used alongside the trial drug, as determined by the treating doctor.
• People aged 18 or older.
• People with a reasonably good level of physical functioning (a performance score meeting the trial's threshold — confirm specific score requirements with the trial site).
• People who have recovered from side effects of any prior cancer treatment, with only mild or no remaining effects at the time of joining.
• People with adequate blood cell counts, kidney function, and liver function meeting the trial's laboratory thresholds (confirm specific values with the trial site).
• Female participants assigned female at birth who are able to become pregnant must have a negative pregnancy test within 24 hours before starting the trial drug, and must agree to use a highly effective combination contraceptive method (hormonal contraception alone is not permitted) during treatment and for 14 months after the last dose.
• Female participants assigned female at birth who are able to become pregnant must also agree not to donate eggs during the treatment period and for 14 months after the last dose.
• Male participants assigned male at birth must agree to use a condom during any sexual activity with a person who could become pregnant throughout treatment and for at least 11 months after the last dose, regardless of vasectomy status.
• Male participants assigned male at birth must agree not to donate sperm during treatment and for at least 11 months after the last dose.
• People living with HIV, hepatitis B, or hepatitis C may be eligible if their viral levels are undetectable and they are on appropriate treatment (confirm details with the trial site).
• People who have signed a form confirming they understand and agree to participate in the trial.

Who may not be able to join:

• People who have previously been treated with a PRMT5 inhibitor or MAT2A inhibitor (a specific class of experimental drugs — confirm with trial site if unsure).
• People who currently have active, symptomatic cancer that has spread to the brain.
• People who have received radiation therapy to non-brain areas within the past 3 days, or focused brain radiation within the past 14 days, before starting the trial.
• People who have had major surgery within 3 weeks before starting the trial drug (minor procedures such as biopsies or catheter insertions are generally permitted).
• People who have had unstable chest pain (angina) or a heart attack within the past 6 months.
• People who have had moderate to severe heart failure within the past 6 months.
• People with a prolonged heart electrical interval (QTc greater than 500 milliseconds) or a history of a condition called Long QT Syndrome.
• People with severe liver cirrhosis (classified as Child-Pugh class C).
• People with an ongoing medical condition that the lead doctor determines would make trial participation unsafe.
• People who are unable to swallow tablets, or who have conditions that would significantly affect how the body absorbs the trial drug (such as severe nausea, problems with the gut, or significant bowel surgery).
• People who need to take certain medications that strongly affect how the body processes drugs (specifically strong CYP3A4 or P-glycoprotein inhibitors or inducers, or proton-pump inhibitors) and cannot be switched to an alternative before joining.
• People with HIV, hepatitis B, or hepatitis C who have a detectable amount of virus in their blood.
• People who are currently pregnant or breastfeeding.
• People who have an active serious infection requiring intravenous antibiotics.
• People with another cancer that could be confused with the cancer being studied during the trial assessments.

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