Phase 1 Oesophageal Cancer Trial, Recruiting

Written by an AI model from the 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 groups:

• People who have at least one tumour that can be measured using standard imaging criteria.
• People whose side effects from any previous cancer treatment have mostly resolved or are only mild.

Group A – Second-line treatment for stomach, gastro-oesophageal junction, or oesophageal adenocarcinoma:

• People with confirmed advanced or metastatic stomach, gastro-oesophageal junction, or oesophageal adenocarcinoma that cannot be surgically removed, and whose cancer has specific tumour marker profiles (HER2-negative and MSS/pMMR — confirm with trial site).
• People whose cancer got worse during or after one previous round of systemic treatment containing two specific chemotherapy drugs (platinum and fluoropyrimidine), with or without an immunotherapy drug.
• People who agree to provide tumour tissue samples before and during the trial.

Group B – Second-line treatment for oesophageal squamous cell carcinoma (ESCC):

• People with confirmed advanced or metastatic ESCC that cannot be surgically removed.
• People whose cancer got worse during or after one previous round of systemic treatment containing specific chemotherapy combinations, with or without immunotherapy.
• People who agree to share results from a previously performed PD-L1 tumour test using an approved testing method.
• People who agree to provide an archived tumour tissue sample.

Group C – First-line treatment for oesophageal squamous cell carcinoma (ESCC):

• People with confirmed advanced or metastatic ESCC that cannot be surgically removed.
• People who agree to provide a tumour tissue sample before starting the trial.
• People who agree to share results from a previously performed PD-L1 tumour test using an approved testing method.
• People whose kidneys are functioning at or above a certain level, as measured by a creatinine clearance test (confirm with trial site).

Group D – Fourth-line or later treatment for colorectal cancer:

• People with confirmed advanced or metastatic colorectal adenocarcinoma that cannot be surgically removed, with documented genetic tumour markers (RAS, BRAF, and mismatch repair status).
• People for whom, in the treating doctor's assessment, no other standard treatment options with proven benefit remain available in their country — including a range of chemotherapy, targeted, and biological therapies (confirm with trial site for the full list).
• People who received a specific chemotherapy (oxaliplatin) as a preventive treatment after surgery and whose cancer returned during or within six months of finishing that treatment.
• People who agree to provide a tumour tissue sample before starting the trial.

Who may not be able to join:

Criteria that apply to all groups:

• People who have had another type of cancer in the past three years that is still active or has required treatment.
• People who have cancer that has spread to the brain or spinal fluid lining and is causing symptoms or has not been treated, or requires ongoing treatment such as steroids, surgery, or radiation.
• People who have had major surgery requiring general anaesthesia within the past 28 days, are still recovering from surgery, or have surgery planned during the trial period.
• People who have previously been treated with a type of medication called an anti-CCR8 antibody.
• People who have had a severe (Grade 4) allergic or anaphylactic reaction to any monoclonal antibody treatment or to any ingredient in the trial drug.
• People with an active, uncontrolled infection, including hepatitis B, hepatitis C, HIV, or AIDS-related illness.
• People with any other condition that the investigating doctor or trial sponsor believes would affect the reliability of the trial results.

Group A – Additional exclusions:

• People who have already received two or more rounds of systemic treatment for advanced or metastatic disease.
• People who are considered at high risk of developing a hole or abnormal connection in the oesophagus (oesophageal fistula), based on their medical history, symptoms, or imaging results.

Group B – Additional exclusions:

• People who have already received two or more rounds of systemic treatment for advanced or metastatic disease.
• People considered at high risk of developing an oesophageal fistula, based on medical history, symptoms, or imaging.

Group C – Additional exclusions:

• People who have already received one or more rounds of systemic treatment for advanced or metastatic disease.
• People whose cancer returned during or within six months of completing a pre- or peri-surgical chemotherapy course that was intended to cure the cancer.
• People considered at high risk of developing an oesophageal fistula, based on medical history, symptoms, or imaging.
• People with a known genetic enzyme deficiency (dihydropyrimidine dehydrogenase deficiency) or a gene variation that increases the risk of serious side effects from a chemotherapy drug called 5-FU.
• People with known allergies to 5-FU or cisplatin.

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