Phase 2 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:

• People who have given written, signed, and dated consent and are able to follow the trial's treatment and check-up schedule
• People who have been diagnosed (confirmed by lab testing of tissue or cells) with an advanced solid tumour that has stopped responding to standard treatments, or for which no standard treatment is considered suitable or has been declined — specific cancer types include head and neck squamous cell carcinoma, non-small cell lung cancer, colorectal cancer, triple-negative breast cancer, clear cell renal cell cancer, oesophago-gastric cancer (not including gastrointestinal stromal tumour), cervical cancer, ovarian cancer, and pancreatic cancer
• People whose cancer can be measured on scans according to standard criteria (called RECIST v1.1)
• People with a life expectancy of at least 12 weeks
• People who are generally well enough to carry out light daily activities, with minimal or no symptoms limiting activity (a score of 0 or 1 on the ECOG scale)
• People whose blood counts and organ function test results fall within the ranges required by the trial
• People aged 18 or over at the time of giving consent; people aged 16–17 may be considered for certain parts of the trial once the trial team has reviewed enough safety information from adult participants (confirm with trial site)
• People who have a part of their tumour that can safely be biopsied (not a bone metastasis), as this is required for all participants

Who may not be able to join:

• People who have had radiotherapy (other than palliative), hormone therapy for cancer, chemotherapy, targeted therapy, immunotherapy, or any other trial treatment within the previous 4 weeks or 5 half-lives of that treatment (whichever is shorter) before starting this trial
• People who still have side effects from previous treatments rated above Grade 1 in severity (with some exceptions, such as hair loss of any grade, stable mild-to-moderate nerve damage, or hormone-replacement-managed hormonal conditions)
• People whose brain or lining-of-the-brain tumours are rapidly growing or causing worsening symptoms, or whose brain tumours have not yet been treated; people with previously treated brain metastases may be considered if they have not had a seizure, significant neurological changes, or required steroids in the last 2 weeks
• People who are pregnant or breastfeeding, or who plan to breastfeed
• Women who could become pregnant, unless they have had a negative pregnancy test within 7 days before joining and agree to use highly effective contraception plus a barrier method, or to abstain from sex, from the time of that negative test through the trial and for 10 months after the last dose of the trial drug
• Male participants with partners who could become pregnant, unless they agree to use a barrier method of contraception or abstain from sex throughout the trial and for 5 months after the last dose — males must also not donate sperm during this period; those who are not vasectomised must also ensure any partner who could become pregnant uses highly effective contraception or agrees to abstain
• People who have not yet fully recovered from surgery
• People with serious non-cancer health conditions, including serious or uncontrolled infections requiring intravenous antibiotics, or unexplained fever above 38°C within 2 weeks before starting the trial drug
• People who have tested positive for hepatitis B, hepatitis C, or HIV
• People with an active or suspected autoimmune disease, or a history of an autoimmune condition that required systemic steroid or immune-suppressing treatment; people who have had an organ or tissue transplant are also excluded — exceptions include vitiligo, hair loss, type 1 diabetes, psoriasis not requiring ongoing immune-suppressing treatment in the past 2 years, stable autoimmune hypothyroidism managed with hormone replacement, and Raynaud's syndrome
• People currently being treated with high or escalating doses of steroids or immune-suppressing medications (certain low-dose, topical, inhaled, or intermittent steroid uses are permitted — confirm with trial site)
• People with a known allergy to any ingredient in the trial drug UCB4594, including polysorbate 80
• People who had to permanently stop a previous immune checkpoint inhibitor treatment due to serious side effects (some exceptions apply — confirm with trial site)
• People who have had a severe reaction (Grade 3 or higher) to a monoclonal antibody or similar drug infusion
• People who have previously received a treatment targeting HLA-G, ILT2, or ILT4
• People who have received a live, weakened (attenuated) vaccine within 28 days before starting the trial drug
• People whose tumour carries a risk of a dangerous flare-up, such as a sudden increase in size that could block airways or cause other serious complications
• People with significant active lung conditions at the time of screening, including cancer that has spread through the lymph vessels of the lungs, a history of interstitial lung disease or pulmonary fibrosis, or a history of inflammatory lung disease
• People with a condition that causes abnormal bleeding
• People with significant heart disease, including a history of heart failure requiring treatment, a very low heart pumping function, unstable chest pain or heart attack within the past 6 months, poorly controlled chest pain occurring weekly or more, a significant heart rhythm problem within the past 6 months, heart muscle inflammation, or severe valve disease; people with an abnormal heart electrical interval (QTc) on their ECG above certain thresholds are also not eligible (confirm with trial site)
• People who are currently enrolled in, or planning to join, another interventional clinical trial
• People who have another active cancer — however, people who have been treated for a previous cancer and have had no sign of disease for 3 or more years may be eligible
• People for whom the trial investigator believes participation would not be in their best interest for any other reason

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