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 aged 18 or older.
• People with a confirmed advanced or spreading solid tumour cancer that has stopped responding to standard treatments, where no standard treatment is available, where standard treatments could not be tolerated, or where the patient has chosen not to receive standard treatment.
• People whose cancer can be measured on scans using standard criteria (called RECIST v1.1).
• People with a life expectancy of at least 3 months.
• People whose blood counts and organ function meet specific minimum levels — including healthy enough white blood cells, platelets, liver function, kidney function, and blood clotting levels (confirm specific values with trial site).
• People who have had treatment for cancer that has spread to the brain, provided that area has been stable for at least 4 weeks after that treatment.
• People who have recovered from most serious side effects of previous cancer treatments, down to a mild level or none (hair loss and some nerve-related side effects may be excepted).
• People who are generally well enough to carry out light activity and care for themselves — rated 0 or 1 on a standard fitness scale used in cancer trials.
• People who are willing and able to use highly effective contraception (with a failure rate of less than 1%, including a barrier method such as a condom or diaphragm with spermicidal gel) throughout treatment and for at least 6 months after the last dose for women, and at least 3 months after the last dose for men. Egg and sperm donation or banking is not permitted during the trial or for 90 days after the last dose.
• Women who could become pregnant must have a negative pregnancy blood test at screening and again within 72 hours before the first dose of the study drug.
• People who are willing and able to give informed consent and follow the study requirements for the full duration of the trial.
• For the expanded part of the trial — people with confirmed advanced or spreading stomach cancer or cancer at the junction of the stomach and oesophagus, who have already received or could not tolerate standard treatments (specific prior treatment requirements depend on cancer type; confirm with trial site).
• For the expanded part of the trial — people with confirmed advanced or spreading colorectal (bowel) cancer, who have already received or could not tolerate standard treatments (specific prior treatment requirements depend on tumour characteristics; confirm with trial site).

Who may not be able to join:

• People with any condition that the treating doctor believes would put them at unacceptable risk or prevent them from fully participating in the study.
• People who have received chemotherapy, targeted therapy, antibody-based cancer treatment, immunotherapy, hormonal therapy, or any experimental cancer treatment within the past 2 weeks or 5 half-lives of that treatment (whichever is shorter).
• People who have had major surgery within the past 3 weeks.
• People who have received radiation therapy within the past 4 weeks (or certain targeted radiation within the past 7 days), or who have not yet recovered from radiation side effects.
• People with serious or unstable heart conditions, including severe heart failure, uncontrolled high blood pressure, uncontrolled irregular heartbeat, a heart attack within the past 6 months, a specific inherited heart rhythm condition, an abnormal heart reading on an ECG above a set threshold, or other significant heart problems.
• People with serious or unstable medical conditions, including uncontrolled diabetes or an unstable mental health condition.
• People who have had another active cancer in the past 2 years, unless it was a localised cancer considered cured and at low risk of returning (such as certain skin cancers or early-stage cancers in specific locations, at the doctor's judgement).
• People with an active infection that requires treatment (including infections without obvious symptoms that the doctor believes may worsen or interfere with the study).
• People with a current active HIV infection not well-controlled on treatment, active hepatitis B, or detectable hepatitis C (people with previously treated and resolved hepatitis B or C, or HIV with a stable, undetectable viral load on treatment, may still be considered eligible — confirm with trial site).
• People who are pregnant, planning to become pregnant, or currently breastfeeding.

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