Phase 3 Head and Neck 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 are willing and able to sign a written consent form to take part in the study.
• People aged 18 to 75 years old, of any gender.
• People whose general physical functioning is rated at 0 or 1 on a standard activity scale used by doctors (meaning they are fully active or have only minor limitations in physically demanding activity).
• People whose doctors estimate they have a life expectancy of at least 3 months.
• People who have been diagnosed with nasopharyngeal carcinoma (a type of cancer in the back of the nose/throat) that has come back or spread, confirmed by laboratory testing of tissue or cell samples, and where curative treatment is no longer an option.
• People whose cancer has already been treated with a type of immunotherapy called PD-(L)1 inhibitors and at least two rounds of chemotherapy, without success.
• People whose doctors consider them suitable for treatment with one of the following chemotherapy medicines: docetaxel, capecitabine, or gemcitabine.
• People who have at least one tumour that can be measured using standard imaging methods (as defined by RECIST v1.1 guidelines).
• People who are willing to provide a tumour tissue sample (either a stored sample or a newly collected one) for testing of a protein called B7-H3.
• People whose organs (such as liver, kidneys, and bone marrow) are functioning at an adequate level as assessed by the trial team.

Who may not be able to join:

• People who have had another type of cancer in the past 5 years, unless that cancer was fully treated with local treatment only (such as certain skin cancers, early-stage bladder cancer, or early-stage cervical or breast cancers that are considered cured).
• People who have previously received any treatment specifically targeting a protein called B7-H3, including certain antibodies, antibody-drug conjugates, or a type of cell therapy called CAR-T.
• People who have previously been treated with a type of drug called a topoisomerase I inhibitor, or with an antibody-drug conjugate that contains this type of drug.
• People who have not waited long enough after finishing previous cancer treatments before starting this study (confirm specific timeframes with trial site).
• People who received strong full-dose radiotherapy within 4 weeks before starting the study, or lower-dose radiotherapy for symptom relief within 2 weeks before starting, or who plan further radiotherapy to the same area.
• People who received steroid medicines or other medicines that suppress the immune system within 2 weeks before starting the study.
• People who received a live vaccine within 4 weeks before starting the study, or who plan to receive a live vaccine during the study.
• People who have cancer that has spread to the brain stem, the lining of the brain or spinal cord, or who have spinal cord compression.
• People with cancer that has spread to the brain, unless the brain metastases have been treated, are causing no symptoms, are stable, and no further treatment is planned within 2 weeks of starting the study.
• People who have another serious illness that is not well controlled.
• People with a severe heart or blood vessel condition that is not well controlled.
• People with a history of a lung condition called interstitial lung disease or pneumonitis (lung inflammation) that needed steroid treatment, or who currently have this condition.
• People with another ongoing lung condition that is causing significant breathing problems.
• People with autoimmune or inflammatory diseases that have required ongoing whole-body treatment within the past 2 years, or who are currently receiving such treatment.
• People who have fluid build-up around the lungs, heart, or abdomen that is causing symptoms or requires repeated draining.
• People who have had a serious infection within 4 weeks before starting the study.
• People with active tuberculosis (TB).
• People with active hepatitis B or hepatitis C infection.
• People who still have unresolved side effects from previous cancer treatments.
• People who are known to be allergic to any ingredient in the study drug, or who have a history of severe allergic reactions to similar medicines or to infusions of biological medicines.
• People who are pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study.
• People whose health, medical situation, or personal circumstances the trial doctor believes would make safe and meaningful participation in the study difficult.

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