Early Phase 1 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 able to give written consent and are willing to follow the study schedule and requirements.
• Adults aged 18 or older, of any gender.
• People who have been confirmed through a tissue sample (biopsy) to have a specific type of esophageal cancer called squamous cell carcinoma.
• For the dose escalation and dose expansion parts: People whose cancer has continued to grow or who could not tolerate at least one prior treatment course involving an immune checkpoint drug (PD-1 antibody) combined with platinum-based chemotherapy — including cases where the cancer came back during or within 6 months after a pre- or post-surgery version of this treatment.
• For the dose escalation and dose expansion parts: People who have at least one tumour that can be measured using standard imaging criteria (CT or MRI scan results taken within 28 days before signing consent).
• For the neoadjuvant (pre-surgery) group only: People who have not yet received any treatment for their esophageal cancer and who are planning to have surgery after completing pre-surgery treatment.
• People with a general health and activity level rated as 0 or 1 on a standard medical scale (meaning fully active or able to carry out light activity).
• People whose expected survival is at least 12 weeks.
• People who carry a specific immune system marker called HLA*A:0201 and/or HLA*A:1101 (a genetic characteristic confirmed by blood test).
• People whose blood, liver, kidney, heart, and clotting function results meet the specific levels required during the screening period, without needing blood transfusions or medications to artificially boost those results beforehand (confirm specific values with trial site).
• People who are willing to use an approved physical method of contraception during the trial and for 6 months after the last dose; women who could become pregnant must have a negative pregnancy test during screening.

Who may not be able to join:

• People who have had an esophageal stent placed, or whose tumour has grown into nearby major structures (such as the aorta or windpipe) in a way that creates a high risk of bleeding or a hole forming.
• People with uncontrolled fluid build-up around the lungs, heart, or abdomen that needs to be drained frequently.
• People with a known allergy to any ingredient in the study drug.
• People who have previously received an mRNA vaccine.
• People who have had major surgery within 4 weeks before the first dose, or who are expected to have major surgery during the study.
• For the dose escalation and dose expansion parts: People who have received any anti-cancer treatment (such as chemotherapy, radiation, immunotherapy, targeted therapy, or another experimental therapy) within 28 days or 5 drug half-lives before the first dose — whichever is the shorter period, but no less than 14 days.
• People who are expected to need immune-suppressing medications during the 4 weeks before or during the study, except for low-dose steroid nasal sprays, inhalers, or a very low daily dose of oral steroids (confirm acceptable doses with trial site).
• People who have had an organ transplant, bone marrow transplant, or stem cell transplant.
• People who have received a live attenuated vaccine (a type of vaccine made with a weakened live virus or bacteria) within 28 days before the first dose.
• For the dose escalation and dose expansion parts: People who have cancer that has spread to the brain and is causing symptoms, has not been treated, or still requires ongoing treatment — though people whose brain metastases have been treated and have been stable for at least 4 weeks, with no new growth and no longer needing steroids, may be considered (confirm with trial site).
• For the dose escalation and dose expansion parts: People who still have significant side effects from previous cancer treatment that have not recovered to a mild or baseline level, except for hair loss or skin colour changes (confirm with trial site).
• People with a history of autoimmune diseases such as lupus, rheumatoid arthritis, or inflammatory bowel disease — though some conditions such as type 1 diabetes, thyroid conditions managed with replacement therapy, or skin conditions not needing systemic treatment may be considered (confirm with trial site).
• People with a history of severe allergic reactions, uncontrollable eczema, or asthma.
• People with serious uncontrolled health conditions, including unexplained high fever, significant heart failure, poorly controlled high blood pressure, unstable chest pain or a heart attack within the past 3 months, uncontrolled irregular heartbeat, or conditions affecting lung function such as chronic obstructive pulmonary disease or interstitial lung disease.
• People with an active infection currently requiring systemic antibiotic or antiviral treatment, or active tuberculosis.
• People with a known history of HIV, active syphilis, hepatitis B with a high viral load, or active hepatitis C infection.
• People who the trial investigators determine are not suitable for any other reason that could affect the study results or their ability to participate.

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