Phase 1 Colorectal Cancer 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 have signed a consent form agreeing to take part before any screening tests are done (non-English speakers may be eligible with the help of a language assistance service).
• People who are 18 years of age or older at the time of signing the consent form.
• People who have been diagnosed with cancer of the colon or rectum (confirmed by a tissue or cell sample), where the cancer has spread or cannot be surgically removed, and where the cancer can be measured using standard imaging guidelines.
• People whose tumour has been tested for specific gene changes — either having none of certain mutations (KRAS, NRAS, EGFR ectodomain, BRAF V600E — for Cohort A), or having a BRAF V600E mutation (for the BRAF expansion group) — with that testing done on tumour tissue or blood before any chemotherapy was given.
• People who have already received at least one chemotherapy treatment for their advanced colorectal cancer, or whose cancer came back or spread within 6 months of finishing chemotherapy after surgery.
• People who have previously received specific targeted treatments: for Cohort A, a type of therapy targeting EGFR (cetuximab or panitumumab) for at least 16 weeks with a complete or partial response before the cancer progressed; for the BRAF expansion group, both a BRAF-targeted therapy (not regorafenib) and an EGFR-targeted therapy.
• People with a general health and activity level rated at 0 or 1 on a standard medical scale (meaning they are fully active or have only minor limitations in physical activity).
• People who have recovered from the main side effects of prior chemotherapy (with the exception of hair loss or certain nerve-related symptoms), with at least 21 days having passed since their last chemotherapy dose.
• People who have fully recovered from the effects of prior radiotherapy, with at least 7 days having passed since treatment ended.
• People whose blood counts meet minimum levels for white blood cells, red blood cells, and platelets (specific values to be confirmed with the trial site).
• People whose liver function blood test results are within acceptable ranges (specific values to be confirmed with the trial site).
• People whose kidney function is within acceptable ranges, based on blood test results (specific values to be confirmed with the trial site).
• People whose heart's electrical activity (measured by an ECG) shows a specific interval within the acceptable range (confirm with trial site).
• People who are able to swallow and take oral (by mouth) medications.
• People who are either post-menopausal, have had a surgical procedure that prevents pregnancy, or are using effective contraception if sexually active; female patients who could become pregnant must have a negative pregnancy blood test within 7 days before joining.
• People who are willing and able to follow all of the trial's requirements.
• People who have had or currently have another type of cancer may be considered, if that cancer or its treatment is unlikely to interfere with this trial's results, following discussion with the lead investigator.

Who may not be able to join:

• People who have had a severe (Grade 3 or 4) allergic reaction or could not tolerate cetuximab or panitumumab in the past.
• People who have had allergic reactions to drugs with a similar chemical makeup to cetuximab, or who have a history of red meat allergy or illness following a tick bite.
• People in the BRAF expansion group who have had a severe (Grade 3 or 4) allergic reaction or could not tolerate encorafenib or a similar BRAF-targeting drug.
• People who have previously been treated with a type of drug called an ERK1/2 inhibitor.
• People who have brain metastases (cancer that has spread to the brain) that are causing symptoms — though people with stable, symptom-free brain metastases that have not changed for at least 4 weeks and do not require steroid or anti-seizure medication may still be considered.
• People who have cancer that has spread to the lining surrounding the brain and spinal cord (leptomeningeal disease).
• People who have a history of or are currently at risk of certain eye conditions affecting blood vessels in the eye (confirm with trial site).
• People who have had another cancer within the past 3 years, with some exceptions such as certain treated skin cancers, early-stage bladder cancer, or other non-invasive cancers, or solid tumours that were treated successfully with no signs of return for at least 3 years.
• People with significant heart problems, including a heart attack, chest pain requiring intervention, or certain heart procedures within the past 12 months; significant heart failure; serious heart rhythm problems within the past 6 months; or a personal history of fainting due to heart causes, dangerous heart rhythm problems, or cardiac arrest.
• People with blood pressure that remains too high despite current treatment (specific values to be confirmed with the trial site).
• People with an active serious bacterial or fungal infection currently requiring intravenous antibiotics or antifungal medications.
• People who are HIV-positive, unless they meet specific conditions including being on a stable HIV treatment regimen, not needing preventive antibiotics or antifungals, and having controlled HIV levels in the blood (confirm with trial site).
• People with an active hepatitis B or hepatitis C infection, as defined by specific blood test results (confirm with trial site).
• People with digestive system problems that could significantly affect how the body absorbs medication, such as uncontrolled vomiting, certain bowel conditions, or significant bowel surgery.
• People with any other condition that, in the investigator's judgement, would make participation unsafe or make it difficult to follow study procedures.
• People who have had major surgery within 6 weeks before starting the trial, or who have not fully recovered from surgery.
• People who are pregnant or breastfeeding.
• People with medical, mental health, thinking, or other conditions that could affect their ability to understand the study, give informed consent, or follow the study requirements.

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