Phase 2 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:

• Adults aged 19 years or older at the time of signing the consent form
• People who have been diagnosed with colorectal cancer confirmed by a tissue or cell sample test
• People whose colorectal cancer has spread to other parts of the body and cannot be removed by surgery
• People whose colorectal cancer has continued to grow or returned after at least two prior standard chemotherapy treatments (including drugs from the fluoropyrimidine, oxaliplatin, and irinotecan families)
• People who have at least one tumour that can be measured or assessed using standard imaging guidelines (RECIST v1.1)
• People who are generally well enough to carry out light activity and care for themselves, as rated by a standard medical scale (ECOG score of 0 or 1)
• Women who could potentially become pregnant must agree to use an accepted form of contraception until 6 months after finishing the trial treatment, and must show evidence that they are not currently pregnant
• Men who have not had a vasectomy must agree to use an accepted form of contraception themselves and ensure their partner does too, until 3 months after finishing the trial treatment
• People who have been fully informed about the trial, agree to take part voluntarily, and provide written consent

Who may not be able to join:

• People who have recently received radiation therapy, chemotherapy, or biological or hormonal treatments (confirm with trial site for exact timeframes)
• People who had surgery under general anaesthetic within 4 weeks before the screening visit
• People who have brain metastases (cancer that has spread to the brain) that are causing symptoms
• People who have peripheral neuropathy (nerve damage, often felt as tingling, numbness, or pain in the hands or feet)
• People who have had stomach or bowel surgery that may affect how oral medication is absorbed, or who are unable to swallow or take medication by mouth
• People with a serious systemic (whole-body) illness that the trial doctor considers unsuitable for cancer treatment
• People who have a heart or cardiovascular condition identified at screening
• People with a history of another cancer in the past 5 years, other than certain treated skin cancers (basal cell carcinoma), early-stage cervical cancer (carcinoma in situ), or appropriately treated papillary thyroid cancer
• People who have gastrointestinal bleeding or ulcers
• People with a genetic condition called DPD (Dihydropyrimidine Dehydrogenase) deficiency, which affects how certain chemotherapy drugs are processed by the body
• People with conditions affecting how the body processes galactose or lactose (galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption)
• People who have had an allergic reaction to the trial drug (BEY 1107), capecitabine, or 5-FU (fluorouracil)
• People who are HIV positive
• People whose hepatitis B or hepatitis C test results are considered unsuitable by the trial doctor
• People with an active or severe infection
• People currently taking the antiviral medications sorivudine or brivudine
• People currently taking, or who have stopped within 7 days of screening, a combination drug containing tegafur, gimeracil, and oteracil potassium
• People currently taking rifampin (an antibiotic) or azole-type antifungal medications
• People whose blood test results show that bone marrow, kidney, or liver function is not at an adequate level
• Women who are pregnant, breastfeeding, or who return a positive pregnancy test at screening
• People whose treating doctor estimates their life expectancy to be less than 12 weeks
• People who have taken part in another clinical trial and received an investigational drug within 4 weeks before screening
• People who the trial doctor considers unsuitable for any other reason

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