Phase 1 Lymphoma 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
• For the early phases of the trial, people with an advanced or spreading solid tumour or lymphoma where standard treatments have stopped working, are not available, or do not apply to their situation
• People with advanced or spreading non-small cell lung cancer (a specific type of lung cancer) who have previously tried both an immune checkpoint therapy (anti-PD-1/PD-L1) and a platinum-based chemotherapy, and who did not have to stop those treatments due to serious side effects (Cohort A)
• People with advanced or spreading non-small cell lung cancer who have tried platinum-based chemotherapy but have not yet received immune checkpoint therapy, and whose tumour tests positive for a protein called PD-L1 (Cohort B)
• People with advanced colorectal (bowel) cancer who have had no more than two previous cancer treatments, and whose tumour shows a certain level of a protein called TIM-3 (at least 10%) (Cohort C)
• People with other types of advanced solid tumours — including but not limited to small cell lung cancer, womb cancer, anal cancer, ovarian cancer, head and neck cancers, or stomach/oesophageal junction cancer — who have had no more than two previous cancer treatments (Cohort D)
• People who are able to provide a stored tumour tissue sample, or who agree to have a new tumour biopsy taken, so that certain proteins can be tested
• People who are generally well enough to carry out light activity and care for themselves (measured using a standard medical scale scored 0 or 1)
• People with a life expectancy of at least 12 weeks
• People who have at least one tumour that can be measured using standard imaging criteria
• People whose blood counts and organ function (such as liver and kidneys) are at adequate levels, tested within 7 days before starting the trial
• Women who are not pregnant and who, along with male participants, agree to use highly effective contraception to prevent pregnancy during the trial

Who may not be able to join:

• People who are currently pregnant, breastfeeding, or lactating
• People who have had a significant autoimmune disease (where the immune system attacks the body) requiring treatment with immune-suppressing medications, either currently or within the past 5 years
• People who have received any cancer treatment or another experimental treatment within 28 days before starting the trial drug
• People who have previously received both a PD-1 antibody therapy and a TIM-3 antibody therapy at the same time or one after the other (people who have received only one of these may still be eligible — confirm with trial site)
• People who have taken immune-suppressing steroid medications at doses above a certain level (more than 10 mg of prednisone daily or an equivalent dose) within the 2 weeks before starting the trial
• People with an active infection, including HIV, active hepatitis B above a certain level, or active hepatitis C
• People who have had a different cancer (other than the one being studied) within the last 3 years — though some early-stage or non-invasive cancers previously treated with the intent to cure may be considered at the investigator's discretion (confirm with trial site)
• People who have had a documented severe allergic or hypersensitivity reaction to antibody-based therapies, or to any ingredient in the trial drug
• People with brain tumour spread, spinal cord compression, or cancer affecting the lining of the brain or spinal cord that is causing symptoms or is not controlled, and that requires ongoing treatment such as surgery, radiation, or steroids
• People who have not yet recovered from side effects of previous radiation or chemotherapy (with some exceptions for hair loss, nerve damage, and hearing issues — confirm with trial site)
• People who have had an organ transplant
• People who have not fully recovered from a surgical procedure, or who have had major surgery within 4 weeks before starting the trial
• People with significant heart problems or poor heart function (confirm with trial site for specific details)
• People with a lung condition involving scarring or inflammation of the lung tissue, including significant radiation-related lung inflammation
• People with type 2 diabetes, particularly those whose blood sugar levels are not well controlled
• People with other underlying health conditions that, in the treating doctor's opinion, would make receiving the trial drug unsafe or make it difficult to assess side effects
• People who have had active tuberculosis within 1 year before joining the trial
• People with a documented history of certain neurological or mental health conditions, such as epilepsy or dementia, particularly where following the trial requirements may be difficult
• People with a history of ongoing gut (gastrointestinal) inflammation, any active gut inflammation at the time of screening, or who experienced severe gut-related side effects (grade 3 or above) from previous immunotherapy

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