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 given written consent to participate
• Adults aged 18 or older, of any gender
• People who have been diagnosed with a solid tumour — the trial is particularly interested in small cell lung cancer, colorectal cancer, pancreatic adenocarcinoma, gastric (stomach) cancer, and triple negative breast cancer, though other solid tumours may also be considered
• People whose cancer has spread to other parts of the body (metastatic) or whose tumour cannot be surgically removed (locally advanced unresectable)
• People for whom all cancer treatments approved by the European Medicines Agency (EMA) have already been tried and are no longer an option
• People who are largely able to carry out daily activities with little or no limitation (this is measured using a standard scale called ECOG, and a score of 0 or 1 is required)
• People who are able to understand what the trial involves, including its risks and side effects, and who are able to attend all required visits as judged by the trial doctor
• People whose liver is functioning adequately, based on blood tests taken within 28 days before starting the study treatment (confirm with trial site for specific values)
• People whose kidneys are functioning adequately, based on a blood test taken within 28 days before starting the study treatment (confirm with trial site for specific values)
• People whose bone marrow is producing enough blood cells, based on blood test results meeting specific thresholds (confirm with trial site for specific values)
• Women who could become pregnant, and men who are sexually active with women who could become pregnant, must agree to use an appropriate method of contraception throughout the trial and for at least 12 months after the last dose of the study treatment

Who may not be able to join:

• Women who are pregnant (confirmed by a blood test at screening) or who are currently breastfeeding
• Men who intend to father children during the trial or within 12 months after their last dose of the study treatment
• People who have had another cancer in the past 5 years — exceptions may include certain skin cancers (basal cell or squamous cell carcinoma) or cervical cancer in situ that has been treated with the aim of cure
• People who still have unresolved side effects of Grade 2 or higher from previous cancer treatments, except for hair loss or skin colour changes — people with stable, long-standing Grade 2 side effects may be considered after discussion between the trial doctor and sponsor
• People with an ECOG performance score above 2, meaning those who are significantly limited in daily activity
• People who previously could not tolerate a type of chemotherapy called a Top1 inhibitor
• People with active cancer that has spread to the brain or central nervous system — those whose brain metastases have been treated with radiotherapy and have been stable for at least 28 days before the start of the study may be considered (confirm with trial site)
• People with serious other illnesses occurring at the same time
• People with a haemoglobin (red blood cell) level below 9 g/dL
• People who have needed blood transfusions regularly for 3 months or more
• People with significant disorders affecting how the body processes iron, such as sickle cell anaemia, or who are currently using iron-removal (chelation) treatments
• People with iron overload conditions, such as hereditary haemochromatosis
• People with moderate or severe liver disease (as classified by a standard scoring system called Child-Pugh B or C)
• People with a prolonged QTc interval, which refers to an abnormality in the heart's electrical activity detected on an ECG (confirm with trial site)
• People with Multiple Sclerosis or other diseases affecting the protective covering of nerves, Eaton-Lambert syndrome, a history of stroke (bleeding or blockage type) within the last 6 months, or alcoholic liver disease
• People with wounds that are not healing, except for ulcers caused by the cancer itself
• People who have had a severe allergic or anaphylactic reaction to a previous protein-based therapy
• People currently taking the blood-thinning medication warfarin
• People with a known history of HIV infection, unless certain specific conditions are all met regarding treatment stability, immune cell counts, and undetectable viral load (confirm with trial site)
• People with hepatitis B (HBV) infection, unless on stable antiviral treatment for more than 4 weeks with an undetectable viral load; or hepatitis C (HCV) infection, unless the infection has been cured and the viral load is undetectable
• People with a known autoimmune disease, uncontrolled diabetes, vitiligo, or unstable thyroid disease (confirm with trial site)
• People who have been taking high-dose steroid medications (such as dexamethasone at 4 mg or more, or equivalent) for more than 10 days continuously, where reduction or stopping is not possible
• People with other medical or mental health conditions that, in the trial doctor's opinion, could affect the results or prevent completion of the trial
• People with a history of drug or alcohol misuse
• People considered unsuitable for any other reason, as judged by the trial doctor
• People who plan to move during the study in a way that would prevent them from attending scheduled visits
• People currently taking part in another clinical trial, or who have taken an experimental drug or product within the past 4 weeks, or who have previously participated in this same trial

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