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 are 18 years of age or older at the time they sign the consent form.
• People who are able to give written consent to take part in the study.
• People whose general health and ability to carry out daily activities meets a specific performance level (rated 0 or 1 on a standard medical scale, meaning fully active or restricted in strenuous activity only) (confirm with trial site).
• People who are not pregnant at the time of enrolment, and who agree to follow contraception requirements during the trial; this also applies to people whose partners could become pregnant.
• People whose blood tests and organ function results fall within the required ranges when tested within seven days before starting treatment — including blood cell counts, kidney function, liver function, and protein levels (confirm with trial site).
• People whose treating doctor estimates they have a life expectancy of at least 12 weeks.
• People with melanoma whose cancer cannot be surgically removed or has spread, and whose disease has continued to grow during or after treatment with certain immunotherapy drugs (checkpoint blockade therapy targeting PD-1 or PD-L1, used alone or combined with CTLA-4 or LAG-3 therapies).
• People with one of the following cancer types — non-small cell lung cancer, kidney cancer (renal cell carcinoma), Merkel cell carcinoma, bladder cancer, or squamous cell carcinoma of the head and neck — where the cancer has come back or spread, has been confirmed by laboratory testing, cannot be cured by surgery or radiation, is a type where immunotherapy is part of standard treatment, and where the person has already received at least one prior systemic cancer treatment for the advanced or recurrent disease.
• People whose cancer shows measurable tumour activity on scans, assessed using a standard measurement system (RECIST v1.1).

Who may not be able to join:

• People who have been diagnosed with an immune deficiency condition.
• People who have previously had a stem cell, bone marrow, or organ transplant.
• People with a known history of HIV infection.
• People with a history of hepatitis B (active surface antigen) or active hepatitis C infection.
• People who have an active autoimmune disease (not caused by prior immunotherapy) that has needed systemic treatment — such as immune-suppressing or disease-modifying medications — in the past two years. Note: hormone or gland replacement therapies (such as thyroid hormone or insulin) are not considered immune-suppressing and do not fall under this exclusion.
• People who currently have active diarrhoea or bowel inflammation rated at a moderate or higher severity level.
• People with currently active cancer that has spread to the brain or the lining of the brain. People with previously treated brain metastases may be considered if scans show the cancer has been stable for at least two weeks, the person is clinically stable, and no steroid treatment has been needed for at least 14 days before the first study dose.
• People who have had another cancer diagnosis within the past three years, with some possible exceptions (such as certain fully removed skin cancers or specific low-risk cancers) — the treating doctor and study sponsor would assess this on a case-by-case basis.
• People the treating doctor determines to be regular users of illicit drugs, or who have a history of substance misuse including alcohol within the past year.
• People with clinically significant heart disease that affects normal daily activities, including unstable chest pain (angina) or a history of heart failure (moderate to severe).
• People who have had a heart attack within the past six months.
• People who have had a new or worsening blood clot (such as a deep vein thrombosis or pulmonary embolism) within the past six months.
• People whose heart's electrical activity shows a specific measurement above a set threshold on testing (QTcF greater than 470 milliseconds).
• People whose medical history, current condition, or other circumstances the treating doctor believes could interfere with the study results or make participation not in the person's best interest.
• People who have an active infection currently requiring systemic treatment.
• People who have had a severe allergic reaction to any components of the study treatment.
• People who are taking ongoing high-dose steroid therapy (above 10 mg of prednisone or equivalent per day) or other immune-suppressing treatments within seven days before the first study dose.
• People who have already received more than five prior lines of systemic treatment for their advanced or recurrent cancer.
• People who have had radiotherapy within two weeks before starting study treatment, or who have a history of radiation-related lung inflammation (radiation pneumonitis).
• People with a history of severe (grade 3 or 4) autoimmune heart muscle inflammation (myocarditis) or a history of Guillain-Barré Syndrome.
• People with a history of heart failure where the heart's pumping function is measured at less than 40%.
• People with non-small cell lung cancer only: those who have received radiation to the lung at a dose above 30 Gy within six months before the first study dose.
• People who have previously received a therapy targeting IL-21, or the specific investigational drug AB248.
• People who have received any systemic cancer treatment (including experimental treatments) within four weeks — or within five half-lives of that drug if that period is shorter — before the first study dose.
• People who have had major surgery and have not yet fully recovered.
• People who have received a live or live-attenuated vaccine within the past 30 days.
• People who are currently taking any medications that are prohibited under the trial's guidelines.
• People who are capable of becoming pregnant and have a positive pregnancy blood test within 14 days before starting treatment.

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