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:

• Participants (or their legal representative) must be willing and able to give signed consent to take part in the study.
• A confirmed tissue diagnosis of one of the following digestive system cancers is required: stomach cancer (gastric adenocarcinoma), colon or rectal cancer (adenocarcinoma), or certain slow-growing neuroendocrine tumours of the small intestine, colon, or rectum (Grade 1, 2, or well-differentiated Grade 3, with specific lab marker levels — confirm details with trial site).
• Tumour tissue samples (either stored slides from a previous biopsy or a new biopsy, if safely possible) must be available. For stomach cancer specifically, the tumour must test positive for a protein called CDH17 before joining.
• At least one prior course of standard cancer treatment for advanced or spreading disease must have been received, as outlined by recognised cancer treatment guidelines. Treatment options that were approved and available, including targeted therapies relevant to the cancer's specific markers, must have been received or formally declined.
• Participants must be aged between 18 and 85 years old.
• For certain parts of the trial (Phase 1 Dose Expansion and Phase 2), the cancer must be measurable on scans according to standard criteria. This is not required for the earlier dose-finding phase.
• Participants must have a good general level of physical functioning, with limited restrictions on daily activities (confirm specific scoring with trial site).
• A life expectancy of at least 12 weeks is required.
• There must be no known medical reasons why the participant could not receive the procedures or medications used in this trial, including a blood cell collection procedure and certain conditioning medications.
• Blood and other lab test results must meet minimum levels set by the trial, covering blood cell counts, liver function, kidney function, oxygen levels, and protein levels (confirm specific values with trial site).
• The heart must be pumping at sufficient strength, with a specific heart function measurement of at least 50% (confirm with trial site).
• Testing must show the participant is negative for HIV.
• Testing must show the participant is negative for hepatitis B and hepatitis C.
• Women who could become pregnant must have a negative pregnancy test before joining.
• People who could father or become pregnant must agree to use effective contraception or abstain from heterosexual activity for at least 3 months after the last dose of the trial treatment.

Who may not be able to join:

• People who have previously been treated with therapies that specifically target the CDH17 protein.
• People who still have unresolved side effects from previous cancer treatment, unless those side effects are mild (Grade 1 or lower) and have been stable for more than 30 days. Hair loss at any level is not a reason for exclusion.
• People with uncontrolled seizures or cancer that has spread to the brain or spinal cord.
• People with a history of serious allergic reactions to drugs that are chemically or biologically similar to the trial treatment.
• People with uncontrolled Crohn's disease, ulcerative colitis, or other active inflammatory or autoimmune conditions affecting the digestive tract — defined as conditions that required hospitalisation, steroid treatment, or an increase in medication within the past 6 months.
• People where cancer has spread to and involves 50% or more of the liver.
• People with an active infection currently requiring antibiotic treatment (oral or intravenous).
• People currently diagnosed with fluid around the lungs, lung scarring (interstitial lung disease), or a severe level of heart failure (Class III or IV as defined by standard heart failure classifications).
• People currently taking high-dose steroid medication (prednisone 20 mg per day or more, or an equivalent dose of another steroid). Lower doses may be permitted up until a certain point before the blood collection procedure — confirm details with trial site.
• People who have had another cancer diagnosis within the past 5 years, with the exception of certain skin cancers or cervical cancer that was treated with the intent to cure.
• People who are currently breastfeeding or who plan to become pregnant within 9 months of joining the study.
• People with any other serious uncontrolled health condition that the treating doctor considers would make participation unsafe or unsuitable.

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