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 have been diagnosed with advanced or metastatic solid tumour cancer (confirmed by tissue or cell testing) whose cancer has stopped responding to standard treatments, or for whom no standard treatment exists.
• People who have at least one tumour that can be measured using standard imaging guidelines.
• People aged 18 or older, of any gender.
• People whose general health and ability to carry out daily activities falls within a certain range — specifically, a score of 0 (fully active) or 1 (minor limitations) on a standard medical scale used to assess physical functioning.
• People with a life expectancy of at least 12 weeks.
• People whose liver, kidney, blood clotting, and blood cell levels meet specific health thresholds, based on blood tests done within 7 days before starting the trial (confirm specific values with the trial site).
• Women who could become pregnant must have a negative pregnancy test within 7 days before starting the trial. Both men and women who could father or carry a child must agree to use effective contraception from the time of signing consent, throughout the trial, and for 6 months after the last dose.
• People who are willing to take part, understand what is involved, sign a consent form, and follow all trial visit requirements and procedures.

Who may not be able to join:

• People who have previously been treated with a class of cancer drugs called topoisomerase 1 inhibitors — including topotecan, irinotecan, belotecan, or certain antibody-drug conjugates such as sacituzumab govitecan or trastuzumab deruxtecan, among others.
• People with a known allergy or severe reaction to any ingredient in the trial drug TJ101, or who have had a severe allergic reaction to similar types of drugs (monoclonal antibodies) in the past.
• People who have received certain cancer treatments too recently before joining — including specific chemotherapy drugs, radiation therapy, surgery, targeted therapies, immunotherapy, or herbal cancer medicines, within defined time periods before starting the trial (confirm exact timeframes with the trial site).
• People who have recently taken certain medications known to strongly or moderately affect how the body processes a specific liver enzyme (CYP3A4), within 3 half-lives of those medications.
• People who have taken part in another clinical drug trial within 28 days, or 2 half-lives of that drug (whichever is shorter), before starting this trial, or who are currently enrolled in another interventional study.
• People who still have side effects from previous cancer treatments that have not recovered to a mild or resolved level, according to a standard grading scale — with some exceptions at the investigator's discretion (such as permanent hearing loss that does not increase risk).
• People who have a history of non-infectious lung inflammation (interstitial lung disease) that required steroid treatment, who currently have lung inflammation, or where lung inflammation cannot be ruled out based on scan results at screening.
• People with severe dry eye, severe inflammation of the cornea or conjunctiva, or other serious eye conditions that the investigator considers could increase the risk of eye damage.
• People with serious or uncontrolled heart conditions, including: abnormal heart rhythm readings on an ECG beyond a certain threshold; clinically significant irregular heartbeat, unstable chest pain, moderate-to-severe heart failure, or a heart attack within the past 6 months; certain risk factors for a serious heart rhythm problem called Torsades de Pointes; or high blood pressure that remains uncontrolled despite taking more than one blood pressure medication.
• People with active hepatitis B or C infections, unless specific conditions are met — for example, hepatitis B viral levels must be below a certain level, and hepatitis C must be well controlled. Eligibility in these cases would be assessed by the trial sponsor and investigator (confirm with trial site).
• People with a known HIV infection.
• People who have had a serious infection requiring hospitalisation, a blood infection, or severe pneumonia within 4 weeks before starting the trial, or who have recently taken antibiotic treatment (whether for treatment or prevention) within 2 weeks before starting.
• People with active cancer that has spread to the brain or the lining around the brain. People whose brain metastases have been treated, are stable for at least 4 weeks, and require only a low dose of steroid medication may be considered (confirm with trial site).
• People who have had another type of cancer within the past 3 years — with some exceptions for certain early-stage or fully treated skin, breast, cervical, or bladder cancers with no signs of recurrence.
• Women who are currently breastfeeding.
• People who, in the investigator's judgement, have any other health, personal, or practical circumstances that could affect their safety, the reliability of the trial results, or their ability to fully participate.

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