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:

• People who are willing and able to sign a written consent form for the trial.
• People who are 18 years of age or older at the time of signing the consent form.
• People who are generally well enough to carry out daily activities with little or no limitation (a performance level assessed by a doctor, known as ECOG 0 or 1).
• People who have been diagnosed with rectal cancer (a specific type called adenocarcinoma), confirmed through a tissue sample.
• People whose rectal cancer is located within 15 cm of the anal opening, and whose cancer has been staged using ultrasound or MRI as having grown into or through the bowel wall, or having spread to nearby lymph nodes.
• People whose cancer has not spread to other parts of the body (no distant metastases).
• People whose cancer can be measured or evaluated using imaging or clinical assessment, as defined by the trial's protocol.
• People whose tumour has been tested at an approved laboratory and found to be HER2-positive, meaning the cancer cells show high levels of a specific protein (HER2), confirmed by at least one of several approved testing methods.
• People whose tumour testing shows that certain DNA repair proteins are working normally (intact mismatch repair, or microsatellite stable disease).
• People whose tumour testing shows no mutations in the RAS gene (specifically KRAS at several key locations), meaning the cancer is described as "RAS wild-type."
• People whose heart is pumping effectively, with a pumping strength (left ventricular ejection fraction) of 50% or more, as measured by an echocardiogram (heart ultrasound).
• People who test negative for pregnancy within 14 days before starting treatment (required for women who could become pregnant), and who are willing to use an effective method of contraception throughout the study and for 150 days after the last dose of study medication.
• People whose blood test results taken within 14 days before starting treatment show that the kidneys, liver, and blood cell counts are functioning within the levels required by the trial (confirm specific values with the trial site).

Who may not be able to join:

• People whose rectal cancer has come back after a previous period of remission (recurrent cancer).
• People who have previously had radiation therapy, chemotherapy, or surgery for rectal cancer in the pelvic area.
• People whose tumour is causing a blockage in the bowel that is producing symptoms (though people who already have a temporary diverting ostomy may still be considered).
• People who have had another type of invasive cancer within the past 5 years, with the exception of certain skin cancers that have been treated, or early-stage cervical cancer that has not spread.
• People who currently have an active infection that requires treatment with medication throughout the body.
• People who are currently receiving or plan to receive other cancer treatments or experimental therapies while taking part in this trial.
• People with a known history of HIV.
• People with known active Hepatitis B or Hepatitis C infection.
• People with a known long-term (chronic) liver disease in their medical history, such as cirrhosis or certain liver conditions related to fat build-up.
• Women who are pregnant or breastfeeding, or men who are planning to conceive a child during the trial period or within 150 days after the last dose of study medication.
• People with other ongoing medical or psychiatric conditions that the trial doctor considers would make participation inappropriate, such as uncontrolled heart rhythm problems, a heart attack within the past 90 days, severe lung disease, uncontrolled seizures, or certain psychiatric conditions.
• People who have received a live vaccine within 30 days before the planned start of study medication.
• People who have had a major surgical procedure, open biopsy, or serious physical injury within 28 days before enrolling in the trial.
• People who are unable to swallow pills, or who have a significant digestive condition that would prevent medications from being properly absorbed.
• People who are taking certain specific medications that strongly affect how the body processes drugs (strong CYP2C8 inhibitors or strong CYP3A4/CYP2C8 inducers), unless these have been cleared from the body before the trial starts (confirm with trial site).

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