Phase 2 Stomach 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 signed and dated an informed consent form before any trial-related procedures begin, in line with the required guidelines.
• People who, in the trial doctor's judgement, are willing and able to attend scheduled visits, follow the treatment plan, and complete required tests and procedures.
• People who are 18 years of age or older at the time of signing the consent form.
• People who have been diagnosed with a confirmed, inoperable, advanced or metastatic stomach or oesophageal cancer (adenocarcinoma) that tests positive for both the HER2 protein (at a specific level: IHC 3+, or IHC 2+ with ISH+) and the PD-L1 protein (with a combined positive score of 1 or higher), based on tumour tissue testing.
• People whose cancer can be assessed or measured on scans, according to a standard measurement system called RECIST v1.1.
• People who have not previously received treatment aimed at controlling their advanced cancer. Earlier chemotherapy, immunotherapy, or radiotherapy given before or after surgery (but not anti-HER2 targeted treatment) is allowed, provided the last treatment finished at least 6 months before joining the trial.
• People whose general health and ability to carry out daily activities is rated at 0 or 1 on a standard scale used by doctors (ECOG performance status), meaning they are either fully active or have only minor limitations.
• People whose liver, kidney, and blood count results fall within the acceptable ranges required by the trial (confirm with trial site for specific values).
• People whose blood clotting tests fall within the acceptable ranges required by the trial (confirm with trial site for specific values).
• Women who could become pregnant must have a negative pregnancy test within 7 days before starting treatment, must not be breastfeeding, and must use highly effective contraception during treatment and for 4 months after the last dose of zanidatamab and/or pembrolizumab, or 6 months after the last dose of chemotherapy, whichever is later.
• Men who are sexually active with women who could become pregnant must either abstain or use contraception during treatment and for 4 months after the last dose of zanidatamab and/or pembrolizumab, or 6 months after the last dose of chemotherapy, whichever is later, and must not donate sperm during this time.

Who may not be able to join:

• People who have a known allergy or serious sensitivity to any of the trial drugs or their ingredients, or who have a history of severe allergic or anaphylactic reactions to certain types of laboratory-made antibodies.
• People who have previously received any anti-HER2 targeted treatment for their stomach or oesophageal cancer.
• People who have had another cancer in the past 5 years, unless it was a type considered very unlikely to spread or cause death and was treated with the aim of a cure (such as certain skin cancers, early-stage cervical changes, or localised prostate cancer treated surgically).
• People who have untreated cancer that has spread to the brain or spinal cord. People whose brain or spinal cord metastases have already been treated and are stable may still be considered eligible (confirm with trial site).
• People whose heart pumping function (left ventricular ejection fraction) is below 50%, as measured by a heart scan.
• People who have an active autoimmune disease (a condition where the immune system attacks the body). Some exceptions apply, including type 1 diabetes, an underactive thyroid caused by autoimmune thyroiditis that is managed with hormone replacement only, or certain skin conditions not requiring systemic treatment (confirm with trial site).
• People who are currently taking high-dose steroids (more than 10 mg of prednisone or equivalent daily) or other medications that suppress the immune system within 14 days before starting the trial drug.
• People who still have significant side effects from a previous cancer treatment that are rated above a mild level, with some exceptions for hair loss, mild nerve-related symptoms, or other low-grade issues the doctor considers safe.
• People who have a serious uncontrolled medical condition or active infection that, in the trial doctor's opinion, could increase the risks of taking part or receiving the trial drugs.
• People who test positive for HIV, AIDS, active hepatitis B, or active hepatitis C.
• People who have previously received a transplant of tissue or a solid organ from another person.
• People who are in prison or have been involuntarily placed in an institution by a court or legal authority.
• People who are unable to give informed consent because they cannot understand the nature or implications of the trial.
• People who have any other condition, abnormal test result, or medical finding that the trial doctor believes would make the trial drugs unsafe or affect the interpretation of the trial results.
• People who are currently taking part in another interventional clinical trial, or who have received an investigational drug from another trial within 28 days before joining this one.
• People who have a complete absence of a specific enzyme called DPD, or who have taken certain medications known to block this enzyme (including brivudine, sorivudine, or similar drugs) within 4 weeks before enrolling.
• Women who are pregnant, breastfeeding, or planning to become pregnant during treatment or within 6 months after treatment ends.

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