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:

• Adults between 18 and 75 years old (male or female).
• For the early phase of the trial (Phase Ia): People who have been diagnosed with a confirmed solid tumour (any type). For the later phase (Phase Ib): People with either advanced primary liver cancer or advanced primary stomach cancer (including cancer at the junction of the stomach and oesophagus).
• People who have at least one tumour that can be measured using standard imaging methods.
• People who are generally well enough to carry out light activity and care for themselves (confirm with trial site — assessed using a standard medical scoring system called ECOG, with a score of 0 or 1).
• People who are able to understand the trial information and are willing to follow all study requirements.
• People whose doctor estimates they are expected to live longer than 3 months.
• People who are able to have a central venous line (a thin tube inserted into a large vein) placed and are able to help care for it.
• People who have had treated brain metastases (cancer that has spread to the brain) may be eligible, provided the condition has been neurologically stable for at least 4 weeks after treatment and they have not needed steroid medication for at least 2 weeks before the trial starts.
• People in Phase Ia (with some exceptions) who are willing and able to have two or more tumour biopsies — one before the trial starts and one or two during treatment — provided the trial doctor considers this safe.
• People whose liver and kidney function test results fall within the ranges required by the trial (confirm specific values with trial site).
• People with primary liver cancer who have a liver function classification of Child-Pugh Class A or Class B with a score of 7, and no history of a condition called hepatic encephalopathy (a liver-related brain condition).
• People whose bone marrow is producing enough blood cells, without the need for a blood transfusion or growth factor support in the 14 days before their first dose.
• People whose blood clotting test results fall within the ranges required by the trial (confirm specific values with trial site).
• People whose side effects from previous cancer treatments have either returned to their pre-treatment state or are mild (Grade 1 or below), with some exceptions for certain stable, long-term side effects as assessed by the trial doctor.
• Female participants who agree not to breastfeed from the time of screening through to 90 days after the last dose of the study drug.
• People who are able to have children (male or female) and agree to use reliable contraception during the trial and for at least 90 days after the last dose.

Who may not be able to join:

• Women who are pregnant or breastfeeding (unless permanent surgical sterilisation or confirmed menopause has been documented — confirm with trial site).
• People who have taken part in another interventional clinical trial within 2 weeks (or within 5 half-lives of the other trial drug, whichever is shorter) before their first dose in this trial.
• People who have active or untreated cancer that has spread to the brain or spinal fluid lining, or who need radiation or surgery to the brain, or who have needed increasing doses of steroid medication for brain-related reasons in the past 2 weeks.
• People with significant heart problems, including poorly controlled heart failure, a weakened heart pump (with pumping function below 50%), uncontrolled high blood pressure, a serious heart rhythm problem, a prolonged electrical interval in the heart (QTcF greater than 470ms), a heart attack or unstable chest pain within the past 6 months, or a condition called congenital long QT syndrome (exceptions may apply for people with a pacemaker — confirm with trial site).
• People with uncontrolled high blood pressure (above 160/100 mmHg), or a recent history of a hypertensive crisis or hypertensive encephalopathy, as assessed by the trial doctor.
• People who have had a stroke or significant bleeding in the brain within the 6 months before their first dose.
• People with serious lung conditions, including a blood clot in the lungs within the past 3 months, severe asthma, severe chronic obstructive pulmonary disease (COPD), restrictive lung disease, current pneumonia, or a history of non-infectious lung inflammation that required steroid treatment within the past 12 months.
• People with active HIV infection or a history of HIV; people with active hepatitis B or hepatitis C (some exceptions apply for people with stable, well-controlled hepatitis B or certain hepatitis C results — confirm with trial site); people with active syphilis.
• People with a current or past additional cancer diagnosis, with some exceptions for cancers that were fully treated more than 2 years ago with no sign of return, or certain types of early-stage or slow-growing cancers that have been completely removed or do not require treatment (confirm with trial site).
• People who have fluid build-up in the chest, around the heart, or in the abdomen that is causing symptoms and needs to be drained repeatedly.
• People who have received cancer treatment within 3 weeks (or within 5 half-lives of the prior treatment drug, whichever is shorter) before their first dose; for traditional Chinese anticancer medicine, within 3 weeks before the first dose.
• People who have had extensive radiation therapy within the past 4 weeks (some exceptions apply for localised palliative radiation or certain other local treatments — confirm with trial site).
• People who have been taking ongoing steroid tablets (at doses of 10 mg per day of prednisone or equivalent or higher) or other immune-suppressing medications within 2 weeks before their first dose. Topical, inhaled, nasal, and eye-drop steroids are allowed.
• People who have received a live or live-attenuated vaccine (such as some flu or travel vaccines) within 4 weeks before their first dose or during the study.
• People who have a history of stroke or currently active neurological symptoms, with some exceptions for stable long-term conditions that the trial doctor, a neurologist, and the study sponsor agree would not interfere with neurological monitoring during the trial. This also excludes people with active sickle-cell disease affecting the brain or active bleeding in the brain.
• People who are taking medications that cannot be safely used together with urea (a component of the study drug), or who require special caution when combining such medications with urea (enrolment may be possible if the trial doctor determines the risks can be managed — confirm with trial site).
• People with conditions that affect how thirst is recognised in the brain, such as central diabetes insipidus or a condition called SIADH (confirm with trial site).
• People who have needed intravenous antibiotic or antiviral treatment for an active infection within the 14 days before their first dose.
• People who have had major surgery within 4 weeks before their first dose (note: insertion of a central venous line or feeding tube is not considered major surgery for this purpose).
• People who have had a solid organ transplant or bone marrow/stem cell transplant within the past 5 years.
• People with any other medical condition that the trial doctor believes would make participation unsafe, make it difficult to follow the study procedures, or make it hard to interpret the results.
• People who are allergic to the study drug or any of its ingredients, including components called PEI and urea.
• People who have had a severe (Grade 3 or 4) allergic reaction to another protein-based medicine in the past.

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