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:

• Adults aged 18 or older at the time of screening.
• People who are mentally able to understand and sign a consent form.
• People with a good general level of functioning — able to carry out normal daily activities with, at most, mild limitations (confirmed using a standard medical scale called ECOG 0 or 1).
• People whose doctor estimates they have a life expectancy of at least 12 weeks.
• People who weigh more than 40 kg.
• People who have had at least 4 weeks pass since any major surgery.
• People willing to provide blood samples before the study begins.
• People who have a tumour that can be directly injected, can be safely biopsied before and after injection, and who agree to that biopsy if the trial doctor considers it safe.
• People whose blood test results meet minimum levels for immune cells, platelets, and haemoglobin (confirm specific numbers with trial site).
• People whose kidney function tests are within acceptable limits (confirm with trial site).
• People whose blood clotting test results are within acceptable limits (confirm with trial site).
• People whose liver function tests are within acceptable limits (confirm with trial site).

For Phase 1 only — additional criteria:

• People whose cancer has been confirmed by tissue or cell testing, and whose disease is locally advanced or has spread to other parts of the body.
• People whose cancer has continued to grow or spread after standard treatment, or who cannot tolerate standard treatment — having tried at least one prior treatment.

For Phase 2 only — Triple-Negative Breast Cancer (TNBC):

• People confirmed by tissue or cell testing to have TNBC that cannot be cured by surgery, radiation, or other available therapies.
• People who have previously received certain chemotherapy drugs (taxane and/or anthracycline-based treatment), and, where relevant, an approved immunotherapy checkpoint inhibitor.
• People who have measurable disease in areas other than the tumour being injected, as assessed by a standard imaging method called RECIST 1.1.

For Phase 2 only — Melanoma:

• People confirmed by tissue or cell testing to have advanced melanoma that cannot be cured by surgery, radiation, or other available therapies (uveal melanoma is not included).
• People who are not suitable for available therapies or who have declined them may also meet this criterion.
• People who have previously received a specific type of immunotherapy (anti-PD-1/PD-L1, alone or combined with anti-CTLA-4), and whose cancer has stopped responding to that treatment — unless it was considered intolerable by their doctor. People with a specific genetic change in their melanoma (BRAF V600E mutation) should also have received a targeted therapy called a BRAF inhibitor, unless considered intolerable.
• People who have measurable disease in areas other than the tumour being injected, as assessed by RECIST 1.1.

Who may not be able to join:

• People with a history of a primary immune deficiency condition.
• People with a history of autoimmune disease or who need ongoing immune-suppressing medications (except for treated underactive thyroid).
• People who have previously had severe (Grade 3 or higher) immune-related side effects from treatment, unless approved by the medical monitor overseeing the trial.
• People who have had a solid organ transplant and are taking immune-suppressing medications.
• People who have had a blood clot in an artery, stroke, or mini-stroke within the past 12 months.
• People with a history of significant heart failure, a heart rhythm problem requiring treatment in the past 12 months, a heart attack, or unstable chest pain within the past 6 months.
• People whose heart electrical activity test (ECG) shows a certain abnormal reading related to heart rhythm (confirm specific values with trial site).
• People who have previously received radiation therapy directly to the tumour area being considered for injection.
• People currently using blood-thinning (anticoagulant) medications.
• People with an active infection that requires intravenous antibiotics within 7 days before the first treatment.
• People with active, uncontrolled bleeding or a bleeding disorder within 7 days before the first treatment.
• People with a serious or non-healing wound, abnormal tissue connection (fistula), skin ulcer, or non-healing bone fracture within 7 days before the first treatment.
• People with a known HIV infection, active hepatitis B, or hepatitis C infection.
• People with untreated cancer in the brain or spinal cord area, or active and progressing brain tumours or spread of cancer to the lining of the brain.
• People with previously treated brain metastases may be considered, but only if there has been no sign of worsening for at least 4 weeks after brain-directed treatment, confirmed by imaging, and steroid medications have been stopped for at least 2 weeks (confirm with trial site).
• People who have another separate cancer that has not been treated with the aim of cure — with the exception of certain non-spreading skin cancers or certain early-stage bladder cancers.
• People with a serious illness that the trial doctor considers incompatible with participating.
• People with any condition the trial doctor believes would interfere with assessing the treatment or the person's safety.
• People who have previously received IL-12 therapy.
• People who have received any vaccine within 30 days before the first dose.
• People who have received another cancer treatment within 3 weeks before the first dose (or within 5 half-lives of that treatment, whichever is shorter).
• People who have previously been enrolled in this same trial.
• People currently enrolled in another interventional clinical trial (observational studies or follow-up components of a completed trial may be acceptable — confirm with trial site).
• People with a known severe allergic reaction (Grade 3 or higher) to the study treatment or its ingredients.
• People with a known psychiatric condition or substance use disorder that would prevent them from following the study requirements.
• People who are currently pregnant, breastfeeding, or planning to become pregnant within 60 days of treatment. Women who could become pregnant must have a negative pregnancy blood test within 72 hours before the first dose.
• Women who could become pregnant and are not willing to use a highly effective form of contraception during the study.
• People who are unwilling or unable to follow the study procedures.

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