Phase 2 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 been diagnosed with advanced or spreading colorectal cancer that has a specific gene change called KRASG12C, confirmed through laboratory testing of tumour tissue, and who have already received at least one round of chemotherapy for their cancer.
• People whose cancer cannot be surgically removed or has spread to other parts of the body.
• People who have measurable tumours that can be tracked using standard imaging guidelines (confirm with trial site).
• People who are willing to have two small tumour biopsies taken — one before treatment starts and one during treatment.
• People aged 18 or older.
• People who are able to swallow and digest oral (tablet or capsule) medications.
• People whose most recent cancer treatment (chemotherapy, immunotherapy, or other) and any radiation therapy ended at least 7 days before starting the trial.
• People who have recovered from most side effects of previous cancer treatments, with only mild or no remaining effects (hair loss and certain nerve-related side effects from a drug called oxaliplatin are exceptions).
• People who are generally well enough to carry out light activity or desk work — rated 0 or 1 on a standard health scale used by doctors (confirm with trial site).
• People whose recent blood test results meet the following levels: adequate white blood cell counts, platelet counts, and red blood cell levels; liver function within acceptable ranges; and kidney function showing adequate filtering ability (confirm with trial site for exact values).
• People who have read, understood, and signed the official consent form for the trial.
• People who are willing and able to follow all trial instructions and attend required appointments.
• People who are capable of having children and are sexually active must agree to use an approved form of contraception throughout treatment and for at least 6 months after the last dose. Accepted methods include hormonal contraception (pill, patch, injection, implant), a copper intrauterine device (IUD), a condom used together with spermicide, confirmed surgical sterilisation, or bilateral tubal ligation or removal of the fallopian tubes. People who may be pregnant must have a negative pregnancy test during the screening period.

Who may not be able to join:

• People who have previously received certain immunotherapy drugs that target PD-1 or CTLA-4 pathways.
• People who have previously received any treatment that specifically targets the KRASG12C gene mutation.
• People who have a weakened immune system, or who have taken steroid or immune-suppressing medications within 7 days before the first dose.
• People who have an active autoimmune disease that required ongoing medical treatment (such as immune-suppressing drugs or steroids) within the past 2 years. Note: hormone replacement therapies for conditions like thyroid or adrenal problems are not considered immune-suppressing treatment for this purpose.
• People who have active brain metastases (cancer that has spread to the brain), unless the brain metastases have been treated, the person has been neurologically stable for at least 2 weeks, and steroid use is either not needed or is at a low stable or decreasing dose (confirm with trial site).
• People who regularly take certain medications that cannot be safely switched to an alternative within 10 days before starting the trial — specifically medications known to affect heart rhythm, or those that interact with certain liver enzymes or drug transporters involved in how the study drugs are processed by the body (confirm with trial site for specific medications).
• People who are pregnant.
• People who are breastfeeding or planning to breastfeed during the study or within 6 months after finishing treatment.
• People who have symptoms caused by cancer spreading to the membranes surrounding the brain and spinal cord.
• People who have had major surgery within 4 weeks before starting the trial.
• People with a history of significant bowel disease or major stomach surgery that may affect how the body absorbs the study medications, as assessed by the treating doctor.
• People with an active HIV infection with detectable virus, or active hepatitis B or C infection. People with well-controlled HIV, resolved or inactive hepatitis B, or successfully treated hepatitis C with no detectable virus may still be considered eligible (confirm with trial site).
• People with any serious or uncontrolled illness, active infection, or other medical or mental health condition that, in the doctor's judgement, would interfere with safe participation in the trial or make the results difficult to interpret.

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