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 are considered adults under the laws of the country where they are enrolling.
• Women who are confirmed not to be pregnant (by blood test and medical interview), and who either cannot become pregnant or agree to use reliable contraception from the time of signing consent until at least 6 months after the last dose of the study treatment (or longer in some treatment groups and countries).
• Women who agree not to breastfeed from the screening stage through to at least 6 months after the last dose of study treatment.
• Women who agree not to donate eggs from the screening stage through to at least 6 months after the last dose of study treatment.
• Men with a partner who could become pregnant (or who is breastfeeding) who agree to use contraception throughout treatment and for at least 6 months after the last dose (or longer in some treatment groups and countries).
• Men who agree not to donate sperm during treatment and for at least 6 months after the last dose of study treatment.
• People whose tumour tissue tests positive for a protein called CLDN18.2, confirmed by a central laboratory test.
• People whose cancer has been confirmed by imaging scans to be either locally advanced and unable to be surgically removed, or to have spread to other parts of the body, within 28 days before the first dose.
• People who have at least one area of cancer that can be measured on imaging scans, within 28 days before the first dose.
• People whose heart electrical reading (a specific measurement called QTcF) is 470 milliseconds or less.
• People who agree not to join another interventional clinical trial while receiving treatment in this study.
• People who are in good enough general health to carry out everyday activities with no more than mild limitations (a standard health score of 0 or 1).
• People with a life expectancy of at least 12 weeks.
• People whose recent blood test results meet the specific laboratory values required by the trial (tested within 7 days before the first dose; if a recent blood transfusion was received, tests must be done at least 1 week after that transfusion).
• People with stomach cancer or cancer at the junction of the stomach and oesophagus (gastric/GEJ cancer) that has been confirmed by tissue testing as adenocarcinoma, and whose disease is locally advanced, unresectable, or has spread to other parts of the body (specific prior treatment requirements vary depending on which treatment group a person would enter — confirm details with the trial site).
• People with pancreatic cancer that has been confirmed by tissue or cell testing as adenocarcinoma that has spread to other parts of the body (specific prior treatment requirements vary depending on which treatment group a person would enter — confirm details with the trial site).
• For some combination therapy groups: people whose tumour tests negative for the HER2 protein by local testing.
• For some combination therapy groups in the EU: people whose tumour has a PD-L1 CPS score of 1 or higher (confirm with trial site).

Who may not be able to join:

• People who have received another experimental treatment, cancer therapy, immunotherapy, or investigational medical device within 21 days (or within a period based on the specific drug's clearance time, whichever is shorter) before the first dose.
• People with any medical condition that the trial team considers would make participation unsafe or unsuitable.
• People with a known allergy or sensitivity to any ingredient in the study treatment, or who have previously had a severe allergic reaction to similar types of antibody-based medicines.
• People who weigh less than 40 kg.
• People who have received immune-suppressing medicines, including steroid tablets or injections, within 14 days before the first dose (low-dose replacement steroids or steroids used as pre-medication for scans may be allowed — confirm with trial site).
• People with a complete blockage of the stomach outlet, or a partial blockage causing ongoing or repeated vomiting.
• People with significant stomach bleeding or untreated stomach ulcers that the trial team determines would make participation unsafe.
• People with brain or spinal cord (CNS) cancer spread that is causing symptoms, or that is unstable even without symptoms. People with previously treated and stable CNS spread, confirmed by imaging for at least 4 weeks before starting the study and not requiring high-dose steroids, may be eligible (confirm with trial site).
• People known to have HIV infection, unless in certain monotherapy groups where a person's immune cell count is sufficiently high and there has been no serious HIV-related infection in the past 6 months (note: people with HIV are not eligible for combination therapy groups).
• People with active hepatitis B or hepatitis C infection (specific testing rules apply — confirm with trial site).
• People who have had unstable chest pain, a heart attack, a serious heart rhythm problem requiring treatment, or hospitalisation for heart failure within the 6 months before the first dose.
• People with an active infection requiring antibiotic or antiviral treatment that has not fully cleared within 7 days before starting the study.
• People with an active autoimmune disease that has required immune-suppressing treatment within the past month before starting the study.
• People with another serious medical condition or illness that could make treatment unsafe or participation unsuitable.
• People with a mental health condition or personal circumstances that would make it difficult to follow the study requirements.
• People who have had major surgery within 28 days before starting the study and have not fully recovered.
• People who have had radiotherapy to the cancer within 14 days before starting the study and have not recovered from any side effects.
• People who have another cancer that currently requires treatment.
• People who have previously received a treatment that specifically targets the CLDN18.2 protein (such as zolbetuximab) are not eligible for the dose escalation part of the trial. People in this situation may be eligible for the dose expansion part only if the previous CLDN18.2 treatment was given more than 28 days or 5 half-lives ago (whichever is longer), and only if they did not experience severe bowel or stomach side effects from that treatment (confirm with trial site).
• People with a history of a lung condition called interstitial lung disease.
• For combination therapy groups: people with a known deficiency of an enzyme called DPD (which affects how certain chemotherapy drugs are processed by the body).
• For combination therapy groups: people with uncontrolled high blood pressure within the 6 months before the first dose.
• For combination therapy groups: people who have needed fluid drained from the abdomen more than twice in the past 7 days.
• For combination therapy groups involving pembrolizumab: people who have received a live-virus vaccine within 30 days before the first dose.
• For combination therapy groups involving pembrolizumab: people with a known immune deficiency condition, or who are on immune-suppressing therapy, or who have had an autoimmune disease requiring systemic treatment in the past 2 years (some replacement hormone therapies may still be allowed — confirm with trial site).
• For combination therapy groups involving pembrolizumab: people with a history of lung inflammation (pneumonitis) that required steroid treatment, or who currently have pneumonitis.
• For combination therapy groups involving ramucirumab and paclitaxel: people who have had a stroke or mini-stroke (TIA) within the past 6 months.
• For combination therapy groups involving ramucirumab and paclitaxel: people with significant blood vessel disease (such as a large aortic aneurysm or recent arterial blood clot) within the past 6 months.
• For combination therapy groups involving ramucirumab and paclitaxel: people with a known bleeding disorder or significant problems with blood clotting.
• For combination therapy groups involving ramucirumab and paclitaxel: people who have newly started blood-thinning medicines of certain types within 28 days before starting the study (people already on these medicines for longer than 28 days may be allowed to continue — confirm with trial site).
• In China specifically: people who have used herbal medicines with known anti-cancer properties within 28 days before the first dose.

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