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 (or the legal age of consent in the country where the trial is taking place)
• People who have a confirmed advanced or metastatic solid tumour (cancer that has spread or cannot be surgically removed) for which standard treatments do not exist, are no longer working, are not tolerated, or have been assessed by the doctor as not suitable
• In Part A of the trial: people with any solid tumour that has a specific genetic change in a pathway called RAS/MAPK (confirm with trial site for additional restrictions)
• In Part B of the trial: people diagnosed with one of the following — melanoma with specific NRAS or BRAF gene changes; or other solid tumours with NRAS, KRAS, or select BRAF gene changes; or glioma (a type of brain tumour) with BRAF gene changes — confirmed by a validated test
• People who can provide either a new or previously collected tumour tissue sample
• In Part B: people whose cancer can be measured using standard imaging assessment methods
• People who are generally well enough to carry out daily activities (as assessed by standard medical scoring tools — confirm with trial site for specific scores required)
• People whose major organs (such as liver and kidneys) are functioning adequately
• People with a life expectancy of at least 12 weeks
• People who are willing and able to give their informed consent before any study-related procedures begin

Who may not be able to join:

• People with conditions that prevent them from swallowing or taking oral (by mouth) medication
• People with conditions that affect how their body absorbs medication taken by mouth
• People with a history of, or current significant problems with their retina (the back of the eye) that could increase certain eye-related risks
• People with a history of, or current significant heart or blood vessel problems
• People who have had inflammation of the lungs (pneumonitis) or scarring of the lung tissue (interstitial lung disease) currently or within the past 6 months
• In Part B: people who have previously been treated with a MEK or BRAF inhibitor drug
• People who have untreated or currently symptomatic cancer that has spread to the brain or spinal cord
• People who have received chemotherapy, radiation, gene therapy, vaccine therapy, or certain cancer-targeting antibody treatments within 28 days before the trial start date
• People who have received certain targeted cancer drugs within 14 days (or within 5 half-lives of the drug) before the trial start date
• People who are pregnant or breastfeeding
• People who are able to have children and are unwilling to use effective contraception during the trial and for 6 months after the last dose of the study drug
• People with any serious or unstable ongoing health condition that the trial team determines would be incompatible with taking part

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