Phase 1 Type 1 Diabetes 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 willing and able to give informed consent to participate.
• People who have a solid tumour cancer that has been confirmed by lab testing (tissue or cell sample) and is either locally advanced or has spread to other parts of the body, and who are not eligible for standard treatment, or whose cancer has stopped responding to or has come back after at least one course of systemic (whole-body) cancer treatment.
• People whose cancer can be measured on imaging scans, based on standard measurement guidelines (RECIST 1.1).
• People who are generally able to carry out daily activities with no or minimal limitations, as rated on a standard medical scale (ECOG performance status of 0 or 1).
• People with a life expectancy of more than three months.
• People whose heart trace (ECG) does not show any significant problems with heart rhythm, electrical conduction, or signs of reduced blood flow to the heart.
• People whose blood counts and organ function meet the required levels, including healthy enough levels of white blood cells, platelets, red blood cells, liver enzymes, kidney function, and blood clotting measures.
• People who have a tumour (original or spread) that can be safely biopsied — this applies to Phase 1B of the trial only.
• Women who could become pregnant must agree to use highly effective contraception during the trial.

Who may not be able to join:

• People who have received another experimental treatment or certain anti-cancer therapies within the past 4 weeks (or within 5 half-lives of the drug, whichever is shorter), or nitrosourea- or mitomycin C-based treatments within the past 6 weeks (note: certain approved hormonal therapies are still permitted).
• People who still have significant side effects from previous cancer treatment that have not resolved to a mild level, with the exception of certain hair loss, nerve-related effects, or managed hormone-related conditions.
• People who have previously received a treatment that targets a protein called CTLA-4.
• People who have previously received treatments targeting certain immune system proteins known as CCR8, CD25, or TIGIT (with an active Fc domain) (confirm with trial site).
• People who have an abnormally long heart electrical interval (QTcF greater than 470 milliseconds) on their baseline ECG.
• People with a history of hepatitis B infection, unless the virus is no longer detectable in the blood.
• People with a known history of hepatitis C infection, unless they have been fully treated and the virus is no longer detectable.
• People with an active or severe infection, such as active tuberculosis.
• People with HIV, unless they are stable on anti-retroviral medication with a sufficiently healthy immune system and very low viral levels in the blood.
• People with significant heart disease, a heart attack within the past 3 months, a stroke within the past 3 months, an unstable irregular heartbeat, or unstable chest pain caused by reduced blood flow to the heart.
• People with an active autoimmune or immune deficiency condition that has required whole-body (systemic) treatment within the past 2 years (note: people whose autoimmune condition is managed with hormone replacement or topical treatments may still be considered eligible).
• People with active or prior inflammatory bowel disease, such as Crohn's disease or ulcerative colitis.
• People who have had a bone marrow or stem cell transplant, or a solid organ transplant (corneal transplants are an exception).
• People who are pregnant or breastfeeding.
• People who have previously had a serious allergic reaction to any ingredient in the trial treatment.
• People currently using systemic (whole-body) steroids within 10 days before enrolling, with certain exceptions such as low-dose replacement therapy, locally applied steroids, or steroids used to prevent allergic reactions to contrast dye used in scans.
• People who have had another active cancer within the past 3 years, with the exception of certain early-stage or localised cancers that have been fully treated (such as certain skin cancers, early breast or cervical changes, or superficial bladder cancer).
• People with brain metastases (cancer that has spread to the brain) that are not considered stable — stability requires two scans at least 4 weeks apart showing no growth, resolved neurological symptoms, and any steroid treatment for this must have been completed at least 10 days before starting the trial.
• People with thymoma or thymic carcinoma — this applies to Phase 1A of the trial only.
• People with other medical or mental health conditions, or abnormal lab results, that the investigator or trial sponsor considers would make participation unsafe or affect the reliability of the trial results.

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