Phase 1 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 a solid tumour (cancer) that tests positive for a protein called HER2, at various levels of expression (ranging from high to low, based on specific lab test results)
• People with hormone receptor-positive breast cancer who have previously been treated with a type of drug called a CDK4/6 inhibitor, in countries where this is considered standard treatment
• People whose blood platelet count, red blood cell levels, and white blood cell counts meet minimum levels as measured by blood tests
• People who have not received a white blood cell-boosting injection (G-CSF) in the 2 weeks before starting the trial
• People whose kidneys are functioning at or above a minimum level, as measured by a specific calculation
• People whose liver enzyme levels (AST and ALT) are within an acceptable range, with slightly higher levels permitted if cancer has spread to the liver
• People whose bilirubin (a substance processed by the liver) is within an acceptable range, with adjusted limits for those with liver involvement or a condition called Gilbert's Syndrome
• People whose blood protein (albumin) level is above a minimum threshold
• People whose blood clotting test results are within an acceptable range, with adjusted limits for those on blood-thinning medication
• People who have waited a sufficient period after major surgery (at least 4 weeks) or radiation therapy (at least 3 weeks, or 2 weeks for palliative radiation) before starting trial treatment
• People who are relatively well and able to carry out daily activities, as measured by a standard scale used by doctors (ECOG score of 0 or 1)
• For the second part of the trial (dose expansion), specific groups may also be eligible, including:
  • People with advanced or metastatic HER2-positive breast cancer who have already received at least two HER2-targeted treatments
  • People with advanced or metastatic breast cancer with low HER2 expression who have received at least one prior treatment, which may have included chemotherapy and/or a HER2-targeted drug
  • People with advanced or metastatic stomach cancer or cancer at the junction of the stomach and oesophagus that is HER2-positive and has been treated with at least one prior therapy, which may have included chemotherapy and/or a HER2-targeted drug
  • People with advanced or metastatic HER2-positive solid tumours who have already received standard treatment, or people with metastatic non-small cell lung cancer with a specific HER2 gene change (mutation) who have received standard treatment
  • People with advanced or metastatic cancer of the oesophagus (adenocarcinoma type) who have received at least one prior standard treatment and whose tumour tests positive for HER2 at specified levels

Who may not be able to join:

• People who have a history of lung inflammation (not caused by infection) that needed steroid treatment, currently have lung inflammation, or where lung inflammation cannot be ruled out by scans at the time of screening
• People with significant breathing difficulties caused by existing lung conditions — such as a blood clot in the lungs within the past 3 months, severe asthma, severe COPD, restricted lung function, fluid around the lungs, or certain autoimmune or inflammatory conditions affecting the lungs — or people who have had a lung surgically removed
• People with moderate or more severe eye inflammation affecting the cornea (the front surface of the eye), or other significant corneal problems
• People with a significant abnormality found during a specialist eye examination, as determined by an eye doctor
• People with significant corneal surface damage, ulcers, or cloudiness of the cornea
• People who wear contact lenses (contact lens use is not permitted during the trial)
• People with cancer that has spread to the brain or spinal cord, unless it has been treated with surgery or radiotherapy and the person has been medically stable — with no worsening neurological symptoms and not requiring steroids (or on a stable or reducing dose for at least 7 days) — for at least 4 weeks before starting the trial
• People with an active second cancer, or a history of another cancer within the past 2 years — with certain exceptions such as treated non-melanoma skin cancers, treated early-stage cancers in situ, certain treated prostate or thyroid cancers, or controlled superficial bladder cancer (confirm with trial site)
• People with significant heart or cardiovascular disease or conditions
• People with significant liver disease
• People with an active serious infection, an infection requiring antibiotics given through a drip, or an unexplained fever above 38°C within the 2 weeks before starting the trial
• People with any other serious, unstable, or life-threatening medical condition — apart from their cancer — that the trial doctor believes could put the person at risk or interfere with the trial

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