Phase 1 Melanoma Trial, Recruiting

Written by an AI model from the 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, of any gender
• People who have been diagnosed with an advanced cancer that has been confirmed by laboratory tissue or cell testing, and who meet specific requirements depending on which phase of the trial they are entering:
  • Dose escalation and single-drug expansion phase: People whose cancer has not responded to standard treatment, who could not tolerate standard treatment, or for whom no standard treatment exists
  • Single-drug therapeutic expansion phase: People with one of the following specific cancers that has continued to grow or spread after certain prior treatments — non-small cell lung cancer (NSCLC), melanoma (skin cancer that cannot be surgically removed), colorectal or rectal cancer with a specific protein marker (PD-L1 CPS score of 1 or higher), kidney cancer (clear cell type), or other advanced cancers with no remaining standard treatment options
  • Combination treatment phase: People with NSCLC, colorectal or rectal cancer (with specific protein marker), kidney cancer, melanoma, liver cancer (HCC meeting specific staging criteria), or other advanced cancers who meet detailed prior treatment history requirements for each cancer type (confirm specific requirements with trial site)
• People whose general health and ability to carry out daily activities is rated as fully active or restricted only in physically strenuous activity (ECOG performance score of 0 or 1)
• People whose doctors estimate they are likely to live for at least 12 weeks
• People who have at least one area of cancer that can be measured using standard imaging criteria (RECIST 1.1)
• People whose liver, kidneys, heart, and blood counts are functioning well enough to meet the trial's standards
• People who are able to have children (both male and female) and agree to use highly effective contraception with their partner throughout the trial and for 6 months after the last dose; women who could become pregnant must have a negative blood pregnancy test within 7 days before the first dose and must not be breastfeeding
• People who are willing to participate voluntarily, have fully understood and signed a written consent form, and are able to follow the trial requirements

Who may not be able to join:

• People who have received chemotherapy, immunotherapy, or other anti-cancer treatments, or experimental drugs within 21 days before the first dose; or oral chemotherapy tablets, small molecule targeted drugs, or certain herbal medicines with anti-cancer indications within 14 days before the first dose
• People who have had major surgery or radiation therapy within 28 days before the first dose (palliative radiation to bone or brain lesions within 14 days may be allowed), or a needle biopsy or minor surgery within 7 days before starting the trial (excluding placement of a medical port or line)
• People who, in the combination treatment phase, have taken corticosteroids at a dose greater than 10 mg of prednisone per day (or equivalent) or other immune-suppressing medicines for more than one week within the 2 weeks before the first dose (inhaled, topical, or low-dose steroids may be allowed — confirm with trial site)
• People who currently have active cancer that has spread to the brain or spinal cord; people whose brain metastases have been treated and are stable may be considered, but people with cancer involving the lining of the brain or brainstem cannot join regardless of treatment
• People who previously had to permanently stop immunotherapy (such as PD-(L)1, CTLA-4, or LAG-3 inhibitor medicines) due to a serious immune-related side effect
• People who have fluid build-up around the lungs, abdomen, or heart that is causing symptoms and requires repeated draining or procedures
• People who have a history of lung disease caused by inflammation of the lung tissue (interstitial lung disease), or who have previously been treated with steroids for non-infectious lung inflammation, or who have signs of active lung inflammation on imaging at the time of screening
• People who have serious wounds that have not healed, active skin ulcers, or untreated broken bones (excluding old fractures that a doctor has determined do not need treatment)
• People who have a notable tendency to bleed easily or a serious problem with blood clotting
• People with poorly controlled high blood pressure (top number 150 mmHg or higher and/or bottom number above 100 mmHg), or a history of a hypertensive crisis or hypertensive brain emergency
• People who still have unresolved side effects from previous cancer treatments that are rated above a mild level (Grade 1 on a standard medical scale), unless the trial site and sponsor agree the side effects are well controlled and will not affect safety
• People who had a serious infection within 28 days before the first dose (such as severe pneumonia, a bloodstream infection, or an infection requiring hospitalisation); or who have an active infection needing intravenous antibiotics, or an unexplained fever above 38.5°C within 2 weeks before the first dose (doctors may still consider people whose fever is believed to be caused by the tumour itself)
• People who have had significant coughing up of blood (50 ml or more per day, or with breathing difficulties) or significant tumour-related bleeding within 1 month before the first dose
• People who have had a bowel perforation, abnormal passage between organs (fistula), abdominal abscess, bowel bleeding, or signs of significant bleeding risk within 6 months before joining (some exceptions may apply for colorectal or stomach cancer patients — confirm with trial site)
• People with serious heart or blood vessel conditions, including a heart attack, severe chest pain (unstable angina), heart failure, significant irregular heartbeat requiring medication, aortic aneurysm needing surgery, arterial blood clots, serious vein clots (Grade 3 or higher), a mini-stroke, or stroke within 6 months before joining; or a heart pumping function (LVEF) below 50%; or a heart rhythm measurement (corrected QTc) above 480 milliseconds
• People who have an active autoimmune disease (where the immune system attacks the body's own tissues) that has required systemic treatment within the past 2 years — such as lupus, multiple sclerosis, rheumatoid arthritis, or inflammatory bowel disease; some conditions such as controlled thyroid disease, Type 1 diabetes managed with hormone replacement, mild skin conditions not needing systemic treatment, or resolved childhood allergies may still be eligible (confirm with trial site)
• People who have had another type of cancer in the past 5 years, with some exceptions for cancers that have been fully cured locally, such as certain early-stage cervical, skin, or prostate cancers
• People with active tuberculosis, active hepatitis B with a high level of virus in the blood, or active hepatitis C with detectable virus in the blood
• People with a history of immune deficiency, a positive HIV test, or a history of receiving an organ transplant or bone marrow/stem cell transplant from another person
• People with other serious physical or mental health conditions, or abnormal test results, that the trial doctor believes would make participation unsafe, affect the person's ability to follow the trial requirements, or interfere with the results

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