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:

Criteria that apply to all parts of the trial:

• Adults aged 18 or older (or the legal age of consent in their country) at the time of signing the consent form.
• People whose cancer tests positive for a protein called CLDN18.2.
• People who have at least one tumour that can be measured on a scan, according to standard measurement guidelines.
• People who are reasonably active and able to care for themselves, with no worsening of their general condition in the 2 weeks before starting treatment (confirm with trial site for specific fitness score details).
• People whose life expectancy is estimated to be at least 12 weeks.
• People whose organs (such as kidneys and liver) and bone marrow are functioning well enough, as defined by the trial protocol.
• People who weigh more than 35 kg.
• People who are willing to follow the trial's contraception requirements.

Sub-study 1 (Stomach or gastroesophageal junction cancer) — additional criteria:

• People with a confirmed diagnosis of a specific type of stomach or gastroesophageal junction cancer (adenocarcinoma), confirmed by tissue testing.
• People whose cancer is advanced or has spread to other parts of the body.
• People who have received no more than 2 previous systemic treatments (such as chemotherapy) for their advanced or metastatic cancer.

Sub-study 2 (Pancreatic cancer) — additional criteria:

• People with a confirmed diagnosis of advanced or metastatic pancreatic cancer (PDAC), confirmed by tissue testing.
• People for whom a stored tumour tissue sample or a new tumour biopsy taken at the screening stage is available.
• People who have not yet received any treatment for their advanced or metastatic disease. Those who received chemotherapy before or after surgery may still be considered, as long as their cancer came back at least 6 months (183 days) after their last dose of that treatment.

Sub-study 3 (Biliary tract cancer) — additional criteria:

• People with a confirmed diagnosis of advanced or metastatic cancer of the biliary tract — including cholangiocarcinoma (inside or outside the liver) or gallbladder cancer — confirmed by tissue testing, and whose cancer cannot be removed by surgery. (Note: cancers of the ampulla of Vater are not eligible.)
• People whose cancer has been shown on scans or clinically to have progressed after at least one previous treatment, and who have received no more than 2 previous systemic treatments for their advanced or metastatic disease.

Who may not be able to join:

Criteria that apply to all parts of the trial:

• People with active or unstable stomach or digestive ulcers, or bleeding in the digestive tract, including significant bleeding related to previous CLDN18.2-targeted treatment.
• People who have significant fluid build-up in the abdomen (ascites) that requires draining.
• People who have previously developed a non-infectious lung condition (ILD or pneumonitis) caused by a medication.
• People who have cancer that has spread to the brain or spinal cord, or other conditions affecting the central nervous system.
• People experiencing moderate or severe nerve damage affecting sensation or movement (Grade 2 or higher) at the time of screening.
• People with a history of another separate primary cancer.
• People who have previously been treated with a specific type of drug called an MMAE-based antibody-drug conjugate (ADC).
• People who have previously received treatments that target CLDN18.2 — except for a specific type called an anti-CLDN18.2 monoclonal antibody, which may be permitted.

Sub-study 1 (Stomach or gastroesophageal junction cancer) — additional exclusion criteria:

• People whose cancer tests positive for a protein called HER2, or where HER2 status is unclear, unless standard HER2-targeted therapy has already been tried, was not tolerated, or is not available to them (confirm with trial site).
• People with heart rhythm conditions or other factors that increase the risk of a specific heart electrical abnormality called QTc prolongation.
• People currently taking medications known to affect heart rhythm (QT/QTc interval).

Sub-study 2 (Pancreatic cancer) — additional exclusion criteria:

• People with a known deficiency of an enzyme called DPD, based on local testing where such testing is standard practice.
• People currently taking strong medications that significantly affect how the body processes certain drugs through pathways called UGT1A1 or CYP3A4 (confirm with trial site for specific drug names).
• People known to carry two copies of a specific genetic variant called UGT1A1*28, based on local testing where such testing is standard practice.

Sub-study 3 (Biliary tract cancer) — additional exclusion criteria:

• People with a significant blockage of the bile ducts that has not been resolved before joining the trial.

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