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 with advanced or spreading solid tumours whose cancer has continued to grow despite standard treatments, who have no remaining standard treatment options, or for whom standard treatments are not suitable (Part 1 – single drug treatment)
• People with locally advanced, inoperable, or spreading cancer of the stomach, the area where the stomach meets the oesophagus (gastroesophageal junction), or the oesophagus (a type called adenocarcinoma) who have not yet received treatment for this advanced stage of disease (Part 2 – combination treatment)
• People with inoperable, locally advanced, or spreading pancreatic cancer (adenocarcinoma type), confirmed by tissue testing (Part 3 – combination treatment)
• People with inoperable, locally advanced, or spreading cancer of the bile ducts or gallbladder (biliary tract cancer), confirmed by tissue testing (Part 4 – combination treatment)
• People who are in generally good physical condition, rated 0 or 1 on a standard medical fitness scale, with organs functioning adequately (confirm with trial site)
• People whose tumour has already been tested for a protein called PD-L1, with a result known as a Combined Positive Score (CPS) on record
• For combination treatment parts (Parts 2, 3, and 4): people whose tumour tests positive for a protein called CLDN18.2

Who may not be able to join:

• People who have previously received a treatment that specifically targets the CLDN18.2 protein
• People who have previously received a type of treatment called a 4-1BB agonist
• People who have been diagnosed with a second cancer within the last 3 years, except for certain skin cancers (squamous cell carcinoma or basal cell carcinoma) or a very early-stage cervical condition called carcinoma in situ
• People with a known active or ongoing hepatitis B or hepatitis C infection, or other forms of hepatitis
• People who have had an unstable or active stomach or digestive tract ulcer, or bleeding in the digestive tract, within the past 6 weeks
• People with an active autoimmune disease (where the immune system attacks the body) that has required medication within the past 2 years
• People with active lung inflammation (interstitial lung disease or pneumonitis), or a history of this condition that required treatment
• People with active, spreading cancer in the brain or the membranes surrounding the brain; people with previously treated brain tumours may be considered if their condition has been stable and they have not needed steroid medication for at least 14 days before starting the study (confirm with trial site)
• People who have experienced significant heart problems — including severe heart failure, unstable chest pain, a heart attack, stroke, mini-stroke, blood clots in the arteries, or certain heart procedures — within the past 6 months
• People with a known immune system deficiency, such as active HIV infection
• People currently receiving intravenous (drip) antibiotics or other intravenous treatments for an active infection
• For combination treatment parts (Parts 2, 3, and 4): people who have previously received certain immunotherapy drugs that target PD-1 or PD-L1 proteins

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