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:

• Adults aged 18 or older who are able to give written agreement to take part in the study
• People who are generally well enough to carry out light activity or desk work (a doctor will assess this using a standard scale)
• People with an advanced solid tumour cancer that has continued to grow after standard treatments, where standard treatments caused unacceptable side effects, where standard treatments were declined, or where no standard treatments exist — and where the tumour meets all of the following conditions:
  • The tumour is not located inside an internal organ (such as the liver or lungs), but may be a skin tumour, a lymph node with cancer, or a tumour that has spread to an area outside an internal organ
  • The tumour can be measured using standard imaging criteria (called RECIST)
  • The tumour can be reached for injection either directly or with the help of ultrasound or CT scan guidance
  • At least 80% of the tumour can be reached for injection with the study device (as assessed by the treating doctor)
  • The tumour is no deeper than 5 cm beneath the skin surface
  • The tumour is not in the eye or brain
• People who have had prior brain tumours (that have spread from elsewhere) may be considered if treatment for those brain tumours finished at least 4 weeks before the start of this study, steroid medicines for that condition were stopped at least 2 weeks ago, and the brain tumours are not causing any symptoms
• People whose blood counts, kidney function, liver function, and blood clotting results are within acceptable ranges as determined by laboratory tests
• People whose side effects from any previous cancer treatments have mostly resolved (to a mild level or better) before starting the study — and any side effects from prior radiation must have fully resolved
• Women who could become pregnant must have a negative pregnancy test within 3 days before starting treatment, and must agree to use highly effective contraception from the time of agreeing to participate until 28 days after treatment ends
• Male participants must agree to use condoms from the time of agreeing to participate until 28 days after treatment ends
• People whose life expectancy is at least 4 months
• People who are able to understand and follow the study procedures for the full duration of the study (as determined by the enrolling doctor)
• People who have previously received radiation to the proposed treatment site may be considered if: at least 6 months have passed since that radiation was given, any radiation side effects at that site resolved at least 3 months ago and did not involve a major organ, and the study radiation oncologist has reviewed the full radiation history and determined the additional study treatment will not pose unacceptable risk (confirm with trial site)
• For the expansion groups only — people with confirmed inoperable, locally advanced, recurrent, or metastatic triple-negative breast cancer (TNBC) or advanced, metastatic, or relapsed soft tissue sarcoma (STS) who have received at least one prior treatment, or who were unable to tolerate or declined standard treatment; additional tumour-specific conditions apply (confirm with trial site)

Who may not be able to join:

• People who are pregnant or currently breastfeeding
• People who have previously been treated with a drug called methoxsalen
• People with a history of allergic or unusual reactions to psoralen compounds (a group of light-sensitising substances) or their ingredients
• People with a medical condition that makes them sensitive to light, including conditions such as lupus, certain types of porphyria, xeroderma pigmentosum, or albinism
• People who have had the lenses of their eyes removed (a condition called aphakia)
• People with a history of allergic or unusual reactions to the components of the study device
• People with a known diagnosis of HIV, hepatitis B, or hepatitis C infection
• People who have an active infection currently being treated with medicines that work throughout the body (with a possible exception for uncomplicated urinary tract infections, at the doctor's discretion)
• People who have another active cancer that is growing and being treated, unless it is basal cell skin cancer, early-stage cervical or bladder cancer, or a cancer for which the person has been cancer-free for at least five years
• People who have received systemic (whole-body) cancer treatment within 28 days, or within 5 half-lives of the drug (whichever is shorter), before starting this study
• People who have received any other experimental treatment within 28 days, or within 5 half-lives of that treatment (whichever is shorter), before starting this study
• People with significant heart problems, including uncontrolled irregular heartbeat, uncontrolled high blood pressure despite two blood pressure medicines, a heart attack or unstable chest pain within the past 6 months, or severe heart failure
• People with other serious uncontrolled health conditions or mental health or social circumstances that would make it difficult to follow the study requirements
• People whose tumour selected for treatment is larger than 300 cc in volume (or larger than 500 cc for soft tissue sarcoma only)
• People currently taking corticosteroid medicines (such as prednisone), or who have taken them recently without at least a one-week break — inhaled or skin-applied steroids are generally permitted
• People with an active autoimmune disease requiring 10 mg or more of prednisone per day and/or biological medicines
• People with a history of pancreatitis or unexplained elevated pancreatic enzyme levels in their blood
• For the TNBC expansion group only — people whose cancer is classified as HER2 ultra-low

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