Phase 2 Oesophageal 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 are willing to sign a consent form and follow the study requirements.
• People who are 18 years of age or older at the time of signing the consent form, of any gender.
• People who are expected to live for at least 12 weeks.
• People who have been confirmed by tissue testing to have advanced, returned, or spread squamous cell cancer of the oesophagus (food pipe), and whose tumour testing shows a positive result for a protein called EGFR (at levels described as IHC 1+, 2+, or 3+).
• People whose cancer has gotten worse or who could not tolerate at least one previous cancer treatment, and where that treatment included an immune checkpoint inhibitor (a type of immunotherapy drug that targets PD-1 or PD-L1).
• People who are able to provide a tumour tissue sample — either from stored tissue or a new biopsy — for laboratory testing.
• People who have measurable signs of cancer progression on imaging scans, with at least one tumour that can be measured and has not been previously treated with radiation (with some exceptions — confirm with trial site).
• People whose side effects from previous cancer treatments have mostly resolved to a mild or absent level before starting the trial (with some exceptions such as hair loss).
• People who have a good general level of physical functioning, as measured by a standard medical scale (score of 0 or 1), assessed within 7 days before the first dose.
• People whose heart is functioning well, with a heart pumping strength of at least 50%, confirmed by a heart scan within 28 days before the first dose.
• People whose blood counts, liver, kidney, and blood clotting results are within acceptable ranges when tested within 7 days before the first dose (specific levels to be confirmed with the trial site).
• People who have not received a blood transfusion within 14 days, or certain blood-boosting medications within 7 days, before the first dose.
• People who are willing to use effective contraception from the time of signing the consent form until 6 months after the last dose of the study drug; women who could become pregnant must have a negative pregnancy blood test within 7 days before starting the study drug.

Who may not be able to join:

• People who have or have had another type of cancer, unless it was certain limited skin cancers, early-stage cervical changes, or another cancer that was fully treated with no signs of return for at least 5 years (confirm with trial site).
• People who have brain metastases (cancer that has spread to the brain) that have not been treated or are not stable, or who have cancer affecting the spinal cord or the lining of the brain.
• People who have large amounts of uncontrolled fluid build-up in the abdomen, chest, or around the heart that cannot be managed, or who needed drainage to manage this fluid within 14 days before the first dose.
• People with severe or poorly controlled other health conditions, such as high blood pressure that is not well managed, poorly controlled diabetes, or signs of active bleeding.
• People with serious heart problems, including significant heart failure, unstable chest pain, a heart attack in the past year, certain heart rhythm problems requiring treatment, or an abnormal heart electrical measurement above a certain level.
• People with active hepatitis B, hepatitis C, or HIV infection, or any other serious uncontrolled infection at the time of starting the trial.
• People who have had a significant allergic reaction to any ingredient in the study drug (vebrekotuzumab), or who have had a severe (Grade 3 or higher) allergic reaction to similar types of protein-based or antibody medicines in the past.
• People with a history of a weak immune system from birth, or who are currently being treated with immune-suppressing medicines or steroid medications at certain doses within 2 weeks before joining the trial (some exceptions apply — confirm with trial site).
• People with a history of or current lung conditions such as interstitial lung disease, radiation-related lung inflammation, severe chronic lung disease, or significant breathing problems.
• People who are pregnant, breastfeeding, or unwilling to use adequate contraception during the study and for 6 months after the last dose.
• People who have any other condition that, in the treating doctor's judgement, would make participation in the trial unsafe or unsuitable.

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