Phase 1 Oesophageal 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 been diagnosed with a gastrointestinal (GI) cancer (such as cancer of the esophagus, stomach, colon, bile ducts, or pancreas, or an unknown primary cancer likely from the GI tract) that cannot be surgically removed or has spread to other parts of the body
• People whose cancer can be measured or assessed on scans according to standard criteria (called RECIST 1.1)
• People whose tumour tests show high levels of a protein called HER2 — specifically IHC 3+ or IHC 2+ with a positive additional test (ISH+) for stomach/esophageal cancers, or IHC 3+ for other GI cancers
• People with stomach or esophageal cancer who have already received at least one HER2-targeted treatment for advanced disease and finished that treatment at least 2 weeks before starting this trial (this requirement does not apply to other GI cancers)
• People who have or have had another cancer, as long as that other cancer or its treatment is unlikely to interfere with this trial's safety or results
• People aged 18 years or older
• People with a general health and activity level rated 0, 1, or 2 on the ECOG scale, meaning they are able to carry out at least some daily activities (confirm with trial site)
• People whose blood counts and organ function (including white blood cells, platelets, liver, kidneys, and other markers) fall within the levels required by the trial
• People whose heart is pumping at least 45% of its capacity, as measured by a heart scan
• People who are willing and able to use effective contraception during the trial and for a set period after the last dose — at least 6 months for women who could become pregnant, and at least 8 months for men whose partners could become pregnant
• People who are able to swallow oral tablet medications
• People who are willing and able to sign an informed consent form agreeing to take part in the trial

Who may not be able to join:

• People who have had chemotherapy or radiotherapy within the 2 weeks before starting the trial, or who are still experiencing side effects from earlier treatment that have not returned to their baseline health
• People who are currently taking part in another clinical trial for advanced cancer, or who have previously been treated with a drug called trastuzumab deruxtecan (T-DxD)
• People who have received immunotherapy or another experimental treatment within 21 days before the trial start date
• People who have untreated brain metastases (cancer that has spread to the brain); people with treated and stable brain metastases may still be considered eligible (confirm with trial site)
• People who are experiencing ongoing diarrhoea (more than 4 bowel movements per day) that has not improved with medical care in the two weeks before starting the trial
• People who have had, or are suspected to have, a lung condition called interstitial lung disease or pneumonitis, or who have significant lung problems requiring oxygen support
• People who have had serious allergic reactions to drugs with a similar chemical or biological makeup to the drugs used in this trial
• People who are currently taking medications that strongly affect how the trial drugs (Neratinib and/or T-DxD) are processed by the body
• People with serious uncontrolled health conditions, such as active infection, heart failure, unstable chest pain, irregular heartbeat, or mental health or personal circumstances that would make it difficult to follow the trial requirements
• People whose heart electrical activity shows a prolonged QT interval on an ECG — specifically above 470 milliseconds for women or above 450 milliseconds for men
• People with uncontrolled HIV (with a CD4 count below 200), or untreated Hepatitis B; people with successfully treated Hepatitis C or well-managed HIV or Hepatitis B with undetectable virus levels may still be considered (confirm with trial site)
• People who are pregnant or breastfeeding

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