Phase 2 Melanoma 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:

• People who are 18 years of age or older (or have reached the legal age of consent where the trial is being run).
• People who are able to give written consent and are willing and able to attend study visits and follow the study procedures.
• People who have an advanced solid tumour (not including lymphoma or other blood cancers) that has continued to grow or spread despite standard treatments, where standard treatments caused intolerable side effects, where standard treatments are not suitable, or where no standard treatment exists.
• People who are in good general health and are able to carry out daily activities with little or no limitation, as measured by a standard health scale called ECOG performance status 0–1 (confirm with trial site).
• People who have measurable disease that can be assessed using specific imaging methods defined by the trial (confirm with trial site for which method applies).
• People who have at least one tumour that can be safely injected directly, either near the surface of the body or inside the body, that meets specific size requirements and does not involve major blood vessels in a way that would create a serious bleeding risk.
• People whose side effects from previous cancer treatments have mostly recovered to a mild or baseline level before joining.
• People whose liver, kidneys, blood clotting, and bone marrow are functioning at adequate levels as defined by the trial (confirm with trial site for specific thresholds).
• People who are willing to provide a tumour tissue sample before and during treatment if it is safe and feasible to do so, and/or who have stored tumour tissue available from within the past two years.
• People of reproductive potential who agree to use effective contraception from the screening period until 30 days after the last dose, and women who could become pregnant must have a negative pregnancy test within 14 days before the first dose.

Who may not be able to join:

• People with a serious psychiatric, medical, or other condition that the study doctor believes would make participation unsafe or interfere with the study.
• People who have had a solid organ transplant (such as a kidney, liver, or heart transplant) at any point in their life.
• People who have a condition called alpha-1 antitrypsin deficiency.
• People who have a bleeding disorder or a condition that affects how their blood clots, whether inherited or developed over time.
• People who have an active autoimmune disease that has required treatment affecting the whole body within the past 6 months (some stable autoimmune conditions in remission may be permitted — confirm with trial site).
• People who have a specific abnormality in their heart's electrical activity (called a QTcF interval greater than 480 ms) at the start of the trial.
• People who are pregnant or currently breastfeeding.
• People who have had a severe immune-related side effect from a previous immunotherapy treatment, including certain types that were life-threatening or affected the nervous system or eyes.
• People who have or have had another active cancer within the past two years, other than the cancer being studied (some low-risk cancers treated with curative intent or under active monitoring may be permitted — confirm with trial site).
• People who have received systemic cancer treatment, including experimental treatments, within 2 to 4 weeks before the first dose (the exact timeframe depends on the type of treatment — confirm with trial site).
• People who have had radiotherapy within 2 weeks before the first dose.
• People who still have side effects from previous cancer treatment that have not resolved to a mild or baseline level (with some specific exceptions — confirm with trial site).
• People who have brain metastases (cancer that has spread to the brain) that are not stable, or people who have cancer affecting the lining of the brain or spinal cord.
• People who have an active infection that requires antibiotics, antifungal, or antiviral medication taken throughout the body within 14 days before the first dose.
• People with certain chronic viral infections, including hepatitis B with detectable virus in the blood without appropriate treatment, active hepatitis C with detectable virus, or HIV with a low immune cell count, detectable virus, or HIV-related illness within the past 6 months.
• People who have used blood-thinning medications (such as warfarin, heparin, or similar drugs) within 14 days before the first dose.
• People who are taking high-dose steroid medications or other medications that suppress the immune system on an ongoing basis (some exceptions for low-dose, short-term, inhaled, or topical use may apply — confirm with trial site).
• People who have a known allergy or sensitivity to the study drug N17350 or any of its ingredients.

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