Phase 1 Colorectal Cancer 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 have an advanced solid tumour cancer that has spread or cannot be removed by surgery, confirmed by pathology records or a current biopsy.
• For the single-drug (monotherapy) part of the trial, people with one of these cancer types may be considered: certain types of non-small cell lung cancer (NSCLC), bladder cancer, colorectal cancer, prostate cancer, ovarian or fallopian tube cancer, or triple-negative breast cancer (a specific subtype confirmed by laboratory testing).
• For the expanded single-drug part, people with certain types of spread colorectal cancer, spread prostate cancer, or tumours that show high levels of a protein called CLDN4 may be considered.
• People whose cancer has continued to grow, who could not tolerate previous treatments, who have declined further standard treatment, or for whom no standard treatments with meaningful benefit are available.
• People who have a tumour sample from within the last 6 months available for testing, or who are willing to have a biopsy taken.
• People who have at least one measurable area of cancer that can be tracked on scans, using standard measurement guidelines.
• People with a general health and activity level rated as 0 or 1 on a standard scale (meaning fully active or able to carry out light work), assessed within 7 days before the first dose.
• People who finished radiotherapy at least 2 weeks before starting the trial treatment.
• People with a life expectancy of at least 12 weeks.
• People whose liver, kidneys, blood, and other organs are functioning well enough, confirmed by blood tests before starting treatment.
• Female participants who are confirmed not pregnant, not breastfeeding, and either cannot become pregnant or agree to use reliable contraception for the required period after the final dose (the timeframe varies depending on which part of the trial).
• Male participants who agree not to donate sperm during treatment and for a set period after the final dose, and who agree to use contraception with partners who could become pregnant for the required period.
• People who agree not to join another interventional clinical trial while taking part in this study.
• For the combination therapy parts, additional specific criteria apply depending on the cancer type and treatment combination, including having particular cancer subtypes confirmed, having received (or not received) specific prior treatments, and being considered suitable to receive the combination drugs used in that part of the trial (confirm specific combination eligibility with the trial site).

Who may not be able to join:

• People who weigh less than 40 kg.
• People who still have significant side effects from previous cancer treatments that have not mostly resolved.
• People who currently have active, uncontrolled cancer spread to the brain or spinal cord, or who have symptoms from brain metastases. People with previously treated and stable brain metastases, with no sign of new growth for at least 4 weeks and not needing high doses of steroids, may still be considered.
• People with an active autoimmune disease or a history of inflammatory bowel conditions such as ulcerative colitis or Crohn's disease. Some conditions, such as type 1 diabetes managed with stable medication or skin conditions not needing systemic treatment, may still be considered (confirm with trial site).
• People who have had a heart attack or unstable chest pain within the past 6 months, or who have uncontrolled heart conditions including heart failure, irregular heartbeat, certain electrical problems in the heart, or severely uncontrolled high blood pressure.
• People with a specific abnormality on a heart tracing (ECG) reading, measured as a QTcF interval above 470 milliseconds, within 7 days before starting treatment.
• People whose heart pumping function (measured by an echocardiogram) is below 45%.
• People with HIV infection, unless their immune system is well controlled, they have had no serious HIV-related infections in the past 6 months, and they are on stable HIV treatment without interactions with the trial drug (confirm with trial site).
• People with certain active hepatitis infections: active hepatitis A (IgM positive), active hepatitis B (positive surface antigen or detectable virus in the blood), or hepatitis C with detectable virus in the blood.
• People with a history of lung inflammation caused by drugs or radiation, a current lung inflammation condition, or a past serious lung inflammation condition that required high-dose steroid treatment.
• People with an uncontrolled ongoing illness, active serious infection, substance use issues, or mental health or personal circumstances that would make it difficult to follow the trial requirements.
• People who have previously received a bone marrow or organ transplant from another person.
• People who have not fully recovered from a major surgery within the 28 days before starting the trial.
• People who have tested positive for COVID-19 within 10 days before starting the trial treatment.
• People who have recently received another experimental treatment, other cancer treatment, or immunotherapy within specific time windows before starting the trial (the exact timeframes vary; confirm with trial site).
• People who are currently taking or have recently taken steroid medications (above a low daily threshold) or other immune-suppressing medications within 14 days before starting the trial drug.
• People who were previously stopped from an immune-based cancer treatment because of a serious, life-threatening immune-related side effect rated grade 3 or higher.
• People who are expected to need another type of cancer treatment at the same time as the trial.
• People who have previously received a treatment targeting a protein called CD137.
• People who have received a live or weakened live vaccine within 28 days before starting the trial.
• People with cancer that has spread to the membranes surrounding the brain and spinal cord (leptomeningeal disease).
• People with a high risk of bleeding or blood-clotting problems related to liver disease, or who have had a clinically significant bleed recently (confirm timeframe with trial site).
• People who have another active cancer (diagnosed within the past 2 years) that requires treatment, apart from certain easily treatable skin cancers or early-stage cancers that have been successfully treated.
• People with any other condition, history, or test result that the treating doctor believes would make participation unsafe or could affect the trial results.
• In China only: people with a positive HIV antibody test result.

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