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 locally advanced rectal cancer (a specific type called adenocarcinoma) confirmed by a lab test, who are planned to receive a full course of treatment before surgery, with the goal of curing the cancer.
• People whose rectal cancer has been classified as Stage II or Stage III, and whose treatment plan includes a full pre-surgery treatment course.
• Adults aged 18 or older (19 or older for people enrolling through Nebraska).
• People who are well enough to carry out basic daily activities, with only mild limitations at most (confirm with trial site).
• People whose blood counts meet minimum levels — including red blood cells, white blood cells, and platelets — based on recent lab tests. Boosting red blood cell levels through transfusion beforehand is acceptable.
• People whose liver function test results are within an acceptable range based on recent blood tests.
• People whose kidneys are working well enough, based on a blood test or urine collection done within the two weeks before enrolling.
• People who have signed a written consent form before any study-related procedures begin.
• Women who could become pregnant must have a negative pregnancy test at the screening stage.
• Women who could become pregnant, and male participants, must agree to use two forms of effective contraception throughout the treatment period and for 12 months after the last study treatment.
• People who have had a chest, abdomen, and pelvis CT scan and a pelvic MRI within 8 weeks before being randomly assigned to a study group.

Who may not be able to join:

• People who are pregnant or currently breastfeeding.
• People who have an active infection that requires antibiotics given through a drip (IV) within the 7 days before enrolling.
• People who are currently being treated for a separate, unrelated cancer — with some exceptions, such as certain skin cancers, cervical carcinoma in situ, cancers that have been free of disease for at least 5 years, previously removed bladder cancer, or low-grade prostate cancer.
• People who have had rectal adenocarcinoma before.
• People who have previously had radiation therapy to the pelvic area for any other cancer.
• People who have a known allergy or medical reason preventing them from receiving the chemotherapy combinations used in this trial (FOLFOX or CAPOX).
• People who are taking corticosteroid medications (such as anti-inflammatory steroids), unless the dose has been stable or decreasing at the time of enrolment.
• People with high blood pressure that is not well controlled (specifically, blood pressure readings above certain levels — confirm with trial site).
• People who have a history of, or currently experience, dizziness or fainting when standing up, or problems with the nervous system that controls automatic body functions, within the past year.
• People with a known allergy to the study drug BMX-001.
• People with significant heart or blood vessel disease — for example, those who have had a stroke or heart attack within the past 6 months, have unstable chest pain, moderate-to-severe heart failure, or a serious irregular heartbeat that is not controlled by medication.
• People with a history of, or signs of, nervous system conditions such as seizures unrelated to cancer, unless well controlled by medication.
• People with significant blood vessel problems — such as a large aortic aneurysm needing surgery, or a recent blood clot in an artery — within the 6 months before starting the study.
• People whose heart's electrical activity (measured by an ECG) shows a prolonged reading above a certain level (confirm with trial site).
• People who have additional risk factors for a specific type of abnormal heart rhythm called Torsades de Pointes — for example, heart failure, low potassium levels, or a family history of a condition called Long QT Syndrome.

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