Phase 1 Melanoma 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 given their voluntary written consent to participate
• People aged 18 years or older
• People who have an advanced solid tumour (such as melanoma, head and neck cancer, cervical cancer, bone cancer, nasopharyngeal carcinoma, breast cancer, lung cancer, colorectal cancer, liver cancer, or stomach cancer) confirmed by laboratory testing of tissue or cell samples
• People whose cancer has continued to grow or spread after at least two previous standard treatments (including targeted therapy), or for whom no suitable standard treatment exists
• People who have at least one tumour that can be measured according to standard criteria (RECIST 1.1)
• People who have at least one tumour that a doctor can access to inject medication directly into it
• People with a general health and activity level rated 0 to 2 on a standard medical scale (ECOG), meaning they are able to carry out everyday activities, at least to some degree
• People expected to live for at least 12 weeks
• People whose liver, kidneys, and bone marrow are functioning adequately
• Women who could become pregnant must have a negative pregnancy test before joining
• People who agree to use effective birth control during the study and for at least 6 months after the last dose

Who may not be able to join:

• People who have brain metastases (cancer that has spread to the brain) causing symptoms, or that have not been treated and stable for at least 3 months
• People who have received radiotherapy to the tumour being considered for injection within the past 2 months
• People who have had another active cancer within the past 5 years (some exceptions may apply — confirm with trial site)
• People whose tumour intended for injection is larger than 100 mm at its longest point
• People who have taken part in another interventional clinical trial within the past 4 weeks
• People who have previously had, or are planning to have, an organ or tissue transplant
• People with an active HIV, Hepatitis B, Hepatitis C, or Syphilis infection meeting certain criteria (confirm with trial site)
• People who require ongoing antiviral medication or blood-thinning (anticoagulation) therapy
• People with a serious, uncontrolled infection rated Grade 3 or higher on a standard medical scale
• People who have not completed the required waiting periods after previous cancer treatments (confirm with trial site)
• People with uncontrolled heart or cardiovascular disease
• People with an active autoimmune disease, or a history of one (some exceptions may apply — confirm with trial site)
• People who need to take corticosteroid medicines above a certain dose (more than 10 mg prednisone or equivalent) within 14 days before joining, or during the study
• People whose tumour is located in an anatomical area considered high-risk for injection (confirm with trial site)
• People who receive live vaccines during the study period
• People with a known allergy or sensitivity to any ingredient in the study drug, or to similar immunotherapy medicines
• People with a history of serious mental illness, substance misuse, or other conditions that may make it difficult to follow the study requirements
• People who are pregnant or breastfeeding
• People who still have side effects from previous cancer treatments that have not improved to a mild level (Grade 1 or lower), except for hair loss
• People considered unsuitable for any other reason, as determined by the doctor running the trial

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