Phase 1 Mesothelioma 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:

• Adults aged 18 or older.
• People whose cancer can be measured on scans or tests according to standard criteria for their cancer type.
• People whose cancer has spread to other parts of the body or cannot be removed by surgery, and who have already received standard treatments, are not suitable for standard treatments, or are unable to receive standard treatments for other reasons.
• People who are reasonably well and able to carry out daily activities, as measured by a standard health scale (a score of 0 or 1 on the ECOG scale — confirm with trial site).
• People who have waited a sufficient period since their last cancer treatment before starting the trial (the exact waiting time depends on the type of treatment previously received — confirm with trial site).
• People whose liver, kidneys, bone marrow, and other organs are functioning well enough, as shown by blood tests.
• People who are able and willing to use effective contraception for the duration of the study, as outlined in the trial protocol, if there is any possibility of pregnancy.
• People who are willing and able to follow all the rules and restrictions set out in the trial protocol.
• People who have signed a form confirming they understand and agree to take part in the trial.
• People who have been diagnosed, by tissue or cell testing, with one of the following cancer types: platinum-resistant ovarian, primary peritoneal, or fallopian tube cancer; stomach or gastroesophageal junction cancer; head and neck squamous cell cancer; recurrent melanoma that has spread or cannot be removed; non-small cell lung cancer; castration-resistant prostate cancer that has spread; malignant pleural mesothelioma; triple-negative breast cancer; locally advanced or metastatic bladder or urinary tract cancer; cervical cancer; a specific type of bowel cancer (MSS colorectal cancer); or a type of lymphoma (DLBCL, including a subtype called DLBCL-RT).
• People who have a tumour that can be safely biopsied (or, for certain lymphoma patients, an accessible lymph node) — this applies to the Phase 1b part of the trial only.

Who may not be able to join:

• People with brain metastases (cancer that has spread to the brain) that are active and have not been treated.
• People with poorly controlled high blood pressure or diabetes, or an active infection that requires ongoing treatment.
• People with ovarian cancer that did not respond to their first platinum-based chemotherapy, or that came back within 6 months of finishing that first treatment (classified as primary refractory EOC).
• People with a mental health condition that would make it difficult to follow the study requirements.
• People who have received certain recent treatments before starting the trial, including: immune checkpoint therapy (such as anti-PD-1 or similar drugs) within the past 3 weeks; a stem cell transplant within the past 100 days; most other systemic cancer therapies within the past 3 weeks or 5 half-lives (whichever is shorter); radiotherapy within the past 2 weeks; certain other specific therapies within the past 6 weeks; or certain medications that affect how the body processes drugs within the past 1–2 weeks (confirm specific timeframes with trial site).
• People who have received CAR-T cell therapy within the past 30 days.
• People who still have significant side effects from previous cancer treatments that have not improved sufficiently (with some exceptions, such as certain types of hair loss or nerve-related side effects — confirm with trial site).
• People who had severe immune-related side effects (Grade 3 or higher) from previous immunotherapy.
• People with a history of uveitis (inflammation of the eye), or an active autoimmune disease that has required treatment with immune-suppressing or disease-modifying medicines in the past 2 years. Note: hormone replacement therapies for conditions such as thyroid or adrenal insufficiency are generally not considered to fall under this restriction (confirm with trial site).
• People who cannot swallow capsules, or who have conditions that significantly affect the absorption of medicines through the digestive system, such as removal of part of the stomach or small intestine, ulcerative colitis, active inflammatory bowel disease, or a bowel blockage.
• People with known allergies or intolerances to any ingredient in the trial drug NX-1607.
• People who are pregnant, breastfeeding, or planning to become pregnant during the study or within 6 months after the last dose of the trial drug.
• Men who plan to father a child during the study or within 3 months after the last dose of NX-1607 (or within 6 months after the last dose of paclitaxel, if applicable).
• People who have had major surgery requiring general anaesthesia within the past 4 weeks, have not fully recovered from surgery, or have surgery planned during the study period or within 4 weeks after the last dose of the trial drug. (People needing minor procedures under local anaesthetic may still be eligible — confirm with trial site.)
• People who have received a live vaccine within the past 28 days, or a COVID-19 vaccine within the past 14 days, before starting the trial. (Standard inactivated flu vaccines are generally exempt — confirm with trial site.)
• People with another active cancer diagnosis, with some exceptions such as: certain well-treated skin cancers or early cervical cancer; a Stage I cancer that has been in full remission for 2 or more years; low-risk prostate cancer meeting specific criteria; or any other cancer from which the person has been free of disease for 2 or more years (confirm with trial site).
• People with HIV that is not well controlled. People with well-controlled HIV (with CD4 count above 350 and undetectable viral load) may still be eligible (confirm with trial site).
• People with currently active hepatitis A, B, or C infection. People who have been successfully treated for hepatitis C with no detectable virus, or who have had past exposure to hepatitis B with a negative PCR test, may still be eligible (confirm with trial site).
• People who have used high-dose corticosteroids (such as prednisone above 20 mg or equivalent) within the past 15 days, or other immune-suppressing drugs within the past 30 days, before starting the trial (with some exceptions — confirm with trial site).
• People who are taking biotin (Vitamin B7) supplements at doses higher than 30 micrograms per day. People who reduce their biotin intake to 30 micrograms per day or less at least one day before their first screening assessment may still be eligible (confirm with trial site).
• People who have taken part in another clinical trial or used an investigational drug or device within the past 3 weeks or 5 half-lives (whichever is shorter).
• People who have experienced any of the following within the past 6 months, or who currently have: a heart attack; unstable chest pain (angina); unstable or symptomatic heart disease; moderate to severe heart failure; blood clots (such as deep vein thrombosis, pulmonary embolism, or stroke-related events); or other serious heart conditions such as fluid around the heart, severe valve problems, or severe congenital heart disease.
• People who, in the opinion of the treating doctor, have any condition or history that could affect their safety, interfere with their ability to complete the study, or make participation not in their best interest.

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