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 who have been diagnosed with one of the following cancer types, confirmed by laboratory tissue analysis: stomach, gastroesophageal junction (GEJ), or esophageal adenocarcinoma; pancreatic adenocarcinoma; or one of several other cancer types including bile duct cancer, colorectal adenocarcinoma, certain lung cancers (NSCLC adenocarcinoma or SCLC), ovarian mucinous carcinoma, or invasive breast cancer (any hormone/HER2 receptor combination).
• People whose cancer has been confirmed by imaging scans to be either locally advanced (unable to be removed by surgery) or has spread to other parts of the body, with scans taken within 28 days before the first dose of the study treatment.
• People in Groups 1–3: those whose cancer can be measured on imaging scans according to standard criteria, with scans taken within 28 days before the first dose of study treatment.
• People in Group 4: those whose cancer can be assessed on imaging scans (whether or not it can be precisely measured), with scans taken within 28 days before the first dose of study treatment.
• People whose tumour has been found to produce a specific protein called CLDN18.2.
• People who have already received at least one prior treatment for their advanced or metastatic cancer.
• People who have a good general level of physical functioning, rated 0 or 1 on a standard medical scale (meaning they are either fully active or restricted in strenuous activity but able to carry out light work).
• People who have a life expectancy of at least 12 weeks.
• Women who are not pregnant — either because they cannot become pregnant, or because a pregnancy test taken at the start of the study was negative — and who agree to use effective contraception from the time they give consent until at least 6 months and 45 days after the last dose of study treatment.
• Women who agree not to breastfeed from the start of the study until at least 6 months and 45 days after the last dose of study treatment.
• Women who agree not to donate eggs from the first dose of study treatment until at least 6 months and 45 days after the last dose.
• Men with female partners who could become pregnant (including breastfeeding partners) who agree to use contraception throughout treatment and for at least 3 months and 45 days after the last dose.
• Men with pregnant partners who agree to remain abstinent or use a condom for the duration of the pregnancy and for at least 3 months and 45 days after the last dose.
• Men who agree not to donate sperm during treatment and for at least 3 months and 45 days after the last dose.
• People whose recent blood test results (taken within 14 days before the first dose) meet all required laboratory thresholds set by the trial.
• People who are willing to provide a tumour tissue sample for central testing as part of the study.
• People who agree not to participate in another interventional clinical trial while receiving this study treatment.

Who may not be able to join:

• People in Groups 1, 2, and 3 whose cancer is not a pure adenocarcinoma, or is a mixed type that includes adenocarcinoma.
• People in Groups 1, 2, and 3 who have already received more than 2 prior treatments for their advanced or metastatic cancer (Group 4 participants may still be considered regardless of number of prior treatments, if no suitable standard treatment options are available or appropriate for them — confirm with trial site).
• People who have a complete or partial blockage of the stomach outlet causing ongoing repeated vomiting.
• People who have significant active stomach bleeding, had a major gastrointestinal bleeding episode within the past 3 months, or have an untreated peptic ulcer.
• People who have significant bleeding disorders or have had inflammation of blood vessel walls (vasculitis) within the past 3 months.
• People who have had a hole or abnormal opening (perforation or fistula) in the gastrointestinal tract within the past 6 months.
• People who have active, untreated cancer spread to the brain or the lining of the brain (meningeal carcinomatosis) — those with stable brain metastases for more than 3 months and who have not needed steroid medication for at least 2 weeks before the first dose may still be considered (confirm with trial site).
• People who have a mental illness that is currently difficult to manage.
• People who have ongoing lung inflammation (pneumonitis) that is not caused by infection, or who needed steroid medication for such a condition within the past 6 months.
• People with a known positive HIV test, active hepatitis B infection, or active hepatitis C infection (certain specific results may still allow eligibility — confirm with trial site).
• People who have an active infection requiring treatment with medicines taken throughout the body that has not fully cleared up within 7 days before the first dose.
• People who currently have another cancer requiring treatment, or who have had a different cancer in the past 5 years — except certain cancers that were fully treated without recurrence, such as some skin cancers, localised prostate cancer, or carcinoma in situ.
• People who have a significant build-up of fluid in the chest or abdomen (such as pleural effusion or ascites) that requires frequent draining or a permanent drain to manage.
• People who still have side effects from previous cancer treatments that have not returned to a mild or resolved level (except hair loss).
• People who have an active autoimmune disease or other condition that currently requires high-dose steroid medication.
• People who have known nerve damage in the hands or feet (peripheral neuropathy) rated above a mild level (except when the only sign is absent reflexes).
• People who have a condition involving blockage or damage to small blood vessels in the liver (sinusoidal obstruction syndrome), unless it is stable or improving (confirm with trial site).
• People who have significant heart problems, including any of the following within the past 6 months: severe heart failure, heart attack, unstable chest pain, certain heart procedures or surgery, stroke, or hypertensive crisis; or a history of serious heart rhythm problems or a need for a permanent pacemaker; or a prolonged heart electrical interval (QTc greater than 470 milliseconds) on an ECG; or a personal or family history of a condition called congenital long QT syndrome.
• People who have ongoing or previous interstitial lung disease, active diverticulitis (inflamed pouches in the bowel), or who have had a solid organ or stem cell transplant.
• People who have a serious wound that is not healing, or a bone fracture, within 28 days before the first dose.
• People who have had major surgery within 28 days before the first dose and have not fully recovered, or who have not recovered from surgery completed within 14 days before the first dose.
• People who have received chemotherapy, immunotherapy, or another investigational treatment within 14 days before the first dose and have not recovered from related side effects (palliative radiotherapy is allowed if completed more than 14 days before the first dose).
• People who have previously received a treatment that targets the CLDN18.2 protein in a specific way known as an antibody-drug conjugate (ADC) — prior treatment with other types of CLDN18.2-targeting therapies may be allowed (confirm with trial site).
• People who have received a live or live-attenuated vaccine within 30 days before the first dose.
• People who are known or suspected to have an allergy or sensitivity to the study drug (ASP546C) or any of its ingredients.
• People who have another significant medical condition that, in the treating doctor's judgement, could make participation unsafe or unsuitable.
• People in Groups 1 and 2 (gastroesophageal adenocarcinoma) whose cancer has been found to be HER2-positive based on standard laboratory testing.

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