Phase 2 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 are 18 years of age or older at the time of signing the consent form.
• People who have been diagnosed with a solid tumour that has spread, cannot be surgically removed, has not responded to previous treatment, or has spread to other parts of the body.
• People whose tumour can be safely reached for biopsy, and who agree to have tumour tissue samples taken during the study.
• People who have at least one tumour that can be measured using a CT scan or MRI, and that has either not been previously treated with radiation or has grown back after radiation.
• People (in certain parts of the study) who have at least one tumour that can be injected directly and measured using CT, MRI, PET-CT, or physical examination.
• People (in certain expansion parts of the study) who have tumours in locations that a doctor considers safe enough to take tissue samples from, both before and during treatment.
• People who have cancer that has spread to the brain, provided that the brain disease is stable, they have no neurological symptoms, and they do not need steroid medication for it.
• People with a general health status rated as 0 or 1 on a standard scale used by doctors to measure how well a person can carry out daily activities (confirm with trial site).
• People who are expected to live for at least 12 weeks.
• People who, in the doctor's opinion, are able to follow all study procedures.
• People who have adequately functioning organs, confirmed by tests done within 4 weeks before the screening stage.
• People of any gender.
• Women of childbearing potential who use contraception in line with local regulations for clinical trial participants.
• People who are able to understand and sign the consent form.

Who may not be able to join:

• People with a known history of HIV/AIDS or who are on related medication.
• People who need ongoing treatment with steroid medicines above a certain dose (more than 10 mg of prednisolone or equivalent per day), or other medicines that suppress the immune system, within 14 days before the first study dose.
• People who have a history of, or currently have, an autoimmune disease or a condition that requires immune-suppressing treatment.
• People who have an active infection currently being treated with antibiotics, being monitored by a doctor, or who have recurring fevers above 38°C linked to an active infection.
• People who have a history of seizures, brain or nervous system conditions, mental health disorders, or heart disease.
• People who have a history of fluid around the lungs, blood clots in the lungs, or bowel obstruction.
• People who have received any cancer treatment (systemic) within 4 weeks or within a certain number of half-lives of the previous treatment, whichever is shorter, before starting the study.
• People who have previously been treated with GM103 or any other oncolytic virus (a type of virus-based cancer therapy).
• People who have had radiation therapy within 2 weeks before joining the study.
• People who have used antiviral medicines within 7 days, or a specific type of immune therapy called pegylated interferon within 14 days, before the first study dose.
• People who have received a live vaccine within 30 days before joining the study.
• People with a serious or uncontrolled medical condition that, in the opinion of the study doctor, could increase health risks, interfere with treatment, or affect how study results are interpreted.
• People who have taken part in another clinical trial within 4 weeks before the first study dose.
• People who have received an experimental (investigational) drug within 28 days before the first study dose.
• People whose heart pumping function is at 50% or below, as measured by a specific heart scan (confirm with trial site).
• People who have had major surgery within 4 weeks before joining the study.
• People who are unable or unwilling to follow study procedures, including taking the study treatment as directed.
• People with any serious medical condition or abnormal laboratory test results (confirm with trial site for specific thresholds).

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