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 aged 19 years or older with a body weight above 30 kg
• People who have been diagnosed with gastric cancer (stomach cancer) that is at an advanced or progressive stage
• People whose stomach cancer has continued to grow or spread during or after 1 or 2 rounds of chemotherapy treatment
• People whose tumour testing (using a gene-sequencing method called NGS) has shown a specific gene change called MET amplification, with a copy number of 4 or higher
• People who have at least one tumour that can be measured on a scan, according to standard medical criteria
• People who are in generally good physical condition, able to carry out everyday activities with no major limitations (a medical rating called ECOG performance status 0–1), and whose condition has not worsened between the initial screening appointment and the first treatment dose
• People with a life expectancy of at least 3 months from the planned start of treatment
• People whose bone marrow, liver, and kidney function test results fall within acceptable ranges, as measured within 28 days before starting treatment (confirm specific values with the trial site)
• People who have waited an appropriate amount of time after their previous treatment before starting the trial — for example, at least 2 weeks after most prior therapies, 4 weeks after radiotherapy or major surgery, and 7 days after minor procedures (confirm exact requirements with the trial site)
• People who are willing and able to follow the trial schedule, including attending all required visits and tests
• Female patients who are not breastfeeding, who test negative for pregnancy, and who agree to use highly effective contraception during the trial and for 3 months after the last dose
• Male patients who agree to use barrier contraception during the trial and for 6 months after the last dose, and who agree to avoid donating sperm during this period
• People who are willing to provide an optional tissue sample (biopsy) before treatment and possibly at the time cancer progresses, if it is medically safe to do so

Who may not be able to join:

• People who have had major surgery within 28 days before the first planned dose (minor local surgery for comfort or pain relief may be acceptable — confirm with trial site)
• People who have previously been treated with a type of drug called a MET inhibitor
• People who have a digestive condition that would prevent them from properly absorbing the study drug taken by mouth — for example, difficulty swallowing, persistent nausea and vomiting, a major bowel removal, bowel obstruction, or significant upper gastrointestinal bleeding within 4 weeks before joining
• People with an active or previously diagnosed autoimmune or inflammatory condition, such as Crohn's disease, ulcerative colitis, lupus, rheumatoid arthritis, tuberculosis, or a history of a primary immune system disorder (confirm with trial site)
• People who have tested positive for HIV, or who have an active tuberculosis infection
• People with active hepatitis B or hepatitis C infection (people with past or resolved hepatitis B infection may still be eligible under certain conditions — confirm with trial site)
• People who have untreated cancer that has spread to the brain or spinal cord; however, people whose brain metastases have already been treated, are stable, and do not require steroid medication for at least 4 weeks may still be considered
• People who have or have had a second separate cancer, unless it was a successfully treated early-stage skin cancer, cervical cancer in situ, or another solid cancer with no sign of return for more than 3 years
• People who are currently taking, or have taken within the past 4 weeks, medicines that suppress the immune system (with some exceptions such as low-dose steroids or inhaled/topical steroids — confirm with trial site)
• People who have received a live vaccine within 30 days before joining the trial or within 30 days of starting study treatment
• People who are currently taking, or cannot stop taking at least 2 weeks before starting the study drug, certain medications that strongly affect how the body processes the study drug (known as potent CYP1A2 inhibitors or strong CYP3A4 inducers — confirm specific medications with trial site)
• People with a significant heart electrical abnormality, specifically a corrected heart rhythm interval (QTc) of 470 milliseconds or more on a heart tracing (ECG)
• People with severe or uncontrolled serious health conditions within the past 6 months, including active infection requiring prescription treatment, uncontrolled diabetes, uncontrolled seizures, severe lung disease, or severe Parkinson's disease
• People who still have unresolved significant side effects (grade 2 or higher) from previous cancer treatment, with the exception of hair loss or skin colour changes
• People with other uncontrolled ongoing illnesses, such as heart failure, uncontrolled high blood pressure, unstable chest pain, irregular heartbeat, interstitial lung disease, serious bowel conditions with diarrhoea, or mental health or social situations that could affect safe participation
• People who are unwilling or unable to use contraception, despite being of an age where pregnancy is possible
• People who have a known allergy or sensitivity to any of the study drugs or their ingredients
• People who have previously received an organ transplant from another person
• People with a past or current history of a specific type of lung inflammation called interstitial lung disease (ILD) (confirm with trial site)
• People with a history of liver cirrhosis of any kind or stage, or other serious liver diseases such as haemochromatosis, autoimmune hepatitis, primary biliary cirrhosis, Wilson's disease, liver cancer, or confirmed advanced liver scarring from alcohol or fatty liver disease

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