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 aged 18 or older at the time of signing the consent form
• People who are willing and able to follow all study procedures and attend appointments at the participating treatment centre
• People whose cancer has been confirmed by laboratory testing as adenocarcinoma of the colon or rectum that has spread to other parts of the body (metastatic) or cannot be surgically removed
• People whose tumour testing shows a high level of a protein called HER2 (either IHC 3+, or IHC 2+ with gene amplification confirmed), according to recognised testing guidelines
• People who have had their tumour tested for RAS gene status and for a DNA repair marker called pMMR/MSS
• People whose cancer can be measured on scans according to standard criteria (RECIST v1.1)
• People whose blood tests show that their heart, liver, kidneys, and blood cell counts are within acceptable ranges, tested within 7 days before starting the trial
• People with a heart pumping function (left ventricular ejection fraction) of 50% or above, measured within 28 days before joining
• People with a life expectancy of at least 3 months
• People with an overall physical functioning score (ECOG performance status) of 0, 1, or 2 — meaning they are able to carry out basic daily activities
• People who are able to provide a tumour tissue sample (either from stored tissue or a new biopsy) for laboratory analysis
• People who have waited long enough after previous treatments before joining — specific waiting periods apply depending on the type of treatment previously received (confirm exact timeframes with the trial site)
• Women who are not able to become pregnant (either post-menopausal for at least 12 months, or surgically sterilised), or women of childbearing potential who have a negative pregnancy test at screening and agree to use at least one highly effective method of contraception from screening until 7 months after the last dose of study treatment
• Women of childbearing potential who agree not to donate eggs or breastfeed from enrolment until at least 7 months after the final study treatment dose
• Men who are not surgically sterilised and are sexually active with a female partner who could become pregnant must agree to use a condom with spermicide from screening until 4 months after the last dose of one study drug, and 6 months after the last dose of another (confirm specifics with the trial site); men must also agree not to donate sperm or attempt to father a child during this period

Who may not be able to join:

• People who have previously received any systemic cancer treatment for colorectal cancer that had spread or could not be removed, or who have taken part in an interventional clinical trial for this stage of colorectal cancer (note: prior treatment in the early-stage setting, completed more than 6 months before joining, may be acceptable — confirm with the trial site)
• People who have previously been treated with an anti-HER2 therapy or a type of chemotherapy called a topoisomerase I inhibitor
• People who have untreated or actively symptomatic cancer spread to the brain or spinal cord, or who need steroids or anti-seizure medication to manage brain metastasis symptoms (people with treated, stable, and symptom-free brain metastases may still be considered)
• People who have difficulty swallowing, problems absorbing food through the gut, or who are unable to take tablets or capsules by mouth
• People with a history of a heart attack within the past 6 months, or with moderate to severe heart failure symptoms
• People with a significantly prolonged heart electrical interval (QTc) on an ECG — above 470 milliseconds for women or 450 milliseconds for men
• People with uncontrolled or symptomatic high blood pressure
• People with a history of lung inflammation (ILD or pneumonitis) that required steroid treatment, or who currently have or may have this condition
• People with significant pre-existing lung conditions such as severe asthma, severe COPD, restrictive lung disease, or a pleural effusion (fluid around the lungs)
• People with autoimmune, connective tissue, or inflammatory conditions (such as rheumatoid arthritis or sarcoidosis) where lung involvement is confirmed or suspected
• People who have had a full removal of one lung (pneumonectomy)
• People who currently have fluid around the lungs, abdomen, or heart that requires drainage or a special procedure to manage
• People with side effects from previous cancer treatment that have not yet settled to mild or baseline levels (some stable, long-standing mild-to-moderate effects may be acceptable — confirm with the trial site)
• People with a known allergy to the study drugs or their ingredients, or to other monoclonal antibody medicines
• People who are pregnant, breastfeeding, or planning to become pregnant
• People who have had another cancer diagnosis within the past 3 years (some exceptions apply, such as certain skin cancers or cancers that have been fully cured — confirm with the trial site)
• People who have a specific inherited variation in a gene called DPYD that affects how the body processes certain chemotherapy drugs (specific variants listed in the trial protocol)
• People who have had a stroke, mini-stroke, heart attack, unstable angina, or certain heart or blood vessel procedures within the past 6 months
• People who have had a significant bleeding event within the past 6 months, unless the cause has been fully treated
• People who have had a hole (perforation) in the stomach or bowel within the past 12 months
• People who have had major surgery within the past 28 days (or longer for certain operations — confirm with the trial site), or who are expected to need major surgery during the trial
• People with a serious wound, ulcer, or bone fracture that has not healed
• People who have had an organ transplant or bone marrow transplant
• People with a known HIV diagnosis
• People with an active hepatitis B or hepatitis C infection (people with a past hepatitis B infection that is currently inactive may be considered under specific conditions — confirm with the trial site)
• People who have received a live vaccine within 30 days before starting the study drug
• People with a psychiatric condition that would prevent them from understanding and agreeing to participation, or from following trial requirements
• People taking certain medications that are not permitted during the trial (confirm the specific list with the trial site)

Additional criteria for people in France and Germany:

• People found to have a deficiency of an enzyme called DPD, based on a blood test showing uracil levels at or above 16 ng/mL
• People who are under legal guardianship, judicial protection, or who are otherwise unable to give their own consent

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