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 at the time of signing the consent form.
• People with a confirmed diagnosis (from a tissue or cell sample) of an advanced or spreading solid tumour cancer that cannot be surgically removed — including, but not limited to, colorectal cancer (CRC), liver cancer (HCC), melanoma, or non-small cell lung cancer (NSCLC).
• People whose cancer has continued to grow or spread despite all standard treatments available to them, or who were unable to tolerate those treatments, or for whom no effective standard treatment exists.
• For the dose expansion part of the trial, people with colorectal cancer who have already tried at least 2 standard chemotherapy regimens and whose cancer progressed or who could not tolerate them (specific prior treatment requirements apply depending on cancer type and genetic features — confirm with trial site).
• For the dose expansion part of the trial, people with melanoma whose cancer progressed on or after treatment with an anti-PD-1 immunotherapy drug (additional requirements apply for people whose tumour has a BRAF V600 mutation — confirm with trial site).
• For the dose expansion part of the trial, people with non-small cell lung cancer whose cancer progressed on or after treatment with an anti-PD-(L)1 immunotherapy drug (additional requirements apply for people whose tumour has a known genetic driver mutation — confirm with trial site).
• For the dose expansion part of the trial, all participants must have a tumour that shows at least 1% expression of a protein called PD-L1 (confirm with trial site).
• People who have at least one tumour that can be assessed or measured using standard imaging criteria.
• People who are reasonably active and able to carry out daily activities, rated 0–2 on a standard medical performance scale (confirm with trial site).
• People with a life expectancy of at least 3 months.
• People whose blood, liver, kidney, and clotting test results meet the required levels at the time of joining the trial (confirm with trial site).
• Women who could become pregnant must have a negative pregnancy blood test within 7 days before starting treatment.
• People who are able to use effective contraception from the time of consent until 6 months after the last dose of study treatment.

Who may not be able to join:

• People with currently active cancer affecting the brain or spinal cord lining (those with previously treated and clinically stable brain involvement may be considered — confirm with trial site).
• People with active hepatitis B or hepatitis C infections, or a known history of HIV/AIDS (people with HIV may be considered if certain immune cell counts and health conditions are met — confirm with trial site).
• People who have had a severe or active infection, including serious pneumonia, blood infection, or active tuberculosis, in the weeks before joining.
• People with a history of active autoimmune diseases such as lupus or rheumatoid arthritis, or who are taking high-dose steroid or other immune-suppressing medications (some exceptions apply — confirm with trial site).
• People with a history of significant scarring or inflammation of the lungs (interstitial lung disease).
• People who still have significant side effects from previous cancer treatments that have not returned to mild or baseline levels (some exceptions apply, such as hair loss or well-controlled nerve or hormone-related side effects).
• People with serious or uncontrolled heart problems, including severe heart failure, poor heart pumping function, abnormal heart rhythm, a recent heart attack or stroke, uncontrolled high blood pressure, or a blood clot in the lungs within the past 6 months.
• People who have previously had a bone marrow transplant or solid organ transplant.
• People who have another active cancer that has been progressing or required treatment within the past 3 years (some skin cancers and localised prostate cancer that have been treated with curative intent are exceptions — confirm with trial site).
• People with a primary immune deficiency disorder or a concurrent serious opportunistic infection.
• People with uncontrolled fluid build-up around the lungs, heart, or abdomen that requires frequent draining (monthly or more often).
• People who have previously received a treatment that targets the TIGIT protein.
• People who have received other anticancer treatments, radiotherapy, or investigational drugs too recently before joining — specific waiting periods apply depending on the treatment type (confirm with trial site).
• People who have received certain immune-boosting drugs (such as thymosin, IL-2, or interferon) within 14 days before starting the trial.
• People who have received a live vaccine within 4 weeks before starting the trial.
• People who have had major surgery within 4 weeks before starting the trial, or who are expected to need major surgery during the trial.
• People who require ongoing blood-thinning (anticoagulant) medication that cannot be safely paused if a study procedure such as a biopsy is needed.
• People who experienced a severe (Grade 3 or higher) immune-related side effect from a previous immunotherapy, or who had to stop immunotherapy because of immune-related side effects (people with stable low thyroid function on hormone replacement may be considered — confirm with trial site).
• People with a known psychiatric condition or substance use disorder that would interfere with following the study requirements.
• People who are pregnant or currently breastfeeding (women willing to stop breastfeeding before starting treatment and not planning to resume may be considered — confirm with trial site).
• People with a known allergy to any ingredient in the study drug.
• People with other serious uncontrolled medical conditions such as severe kidney, liver, lung, pancreatic, or digestive disease, uncontrolled diabetes, active stomach ulcers, uncontrolled seizures, or severe blood clotting problems.
• People who are unwilling or unable to follow the study procedures and requirements.
• People for whom treatment with a PD-1/PD-L1 immunotherapy drug is medically contraindicated (applies to the Phase 1b part of the trial only).

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