Phase 2 Head and Neck 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 fully informed about the trial and have willingly signed and dated a consent form before the trial begins
• People aged between 18 and 75 years (inclusive)
• People who have a confirmed diagnosis (through tissue or cell testing) of non-small cell lung cancer, breast cancer, head and neck cancer, or other advanced or spreading solid tumours — including but not limited to colorectal cancer, HER2-positive stomach cancer, cervical cancer, or ovarian cancer
• People who have at least one measurable tumour site outside the brain, as assessed using standard imaging guidelines (RECIST 1.1)
• People who are able to provide either stored or newly collected tumour tissue samples
• People whose general physical functioning is rated as 0 or 1 on a standard cancer performance scale (meaning fully active or able to carry out light activity)
• People whose organ and bone marrow function meets the required levels within 7 days before the first dose
• People who are willing and able to use highly effective contraception from the screening period until at least 6 months after the last dose of the study drug — this applies to both women who could become pregnant and to men
• People with an expected survival of at least 3 months
• People who are willing and able to attend all required visits and follow the study procedures

Who may not be able to join:

• People who have previously received any treatment specifically targeting HER3, including antibodies, antibody-drug conjugates (ADCs), CAR-T cell therapy, or similar drugs
• People who have previously had a bad reaction or intolerance to a class of drugs called topoisomerase I inhibitors, or to ADC treatments that contain these drugs
• People who are currently taking part in another interventional clinical trial (participation in a non-interventional observational study or a follow-up period of a completed trial may be acceptable — confirm with trial site)
• People who have not waited long enough after their last cancer treatment before starting this trial (confirm with trial site for specific timeframes)
• People who have had major surgery (not including minor diagnostic procedures) within 4 weeks before the first dose, or who are expected to have major surgery during the trial
• People who have previously had an allogeneic bone marrow transplant or a solid organ transplant
• People who have taken high-dose steroid tablets (such as prednisone above 10 mg/day or an equivalent dose) or other immune-suppressing medications within 2 weeks before the first dose
• People who have received a live vaccine within 4 weeks before the first dose, or who plan to receive one during the trial
• People who have cancer that has spread to the membranes surrounding the brain or spinal cord
• People who have cancer that has spread to the brain, or who have spinal cord compression
• People with serious or uncontrolled heart or blood vessel conditions
• People with significant or serious lung conditions
• People diagnosed with Gilbert syndrome (a liver condition affecting bilirubin processing)
• People with uncontrolled fluid build-up in body cavities that requires repeated draining
• People who have had a gastrointestinal perforation or fistula in the 6 months before the first dose, or who have active stomach or bowel ulcers or conditions that could lead to bleeding or perforation
• People who have a serious active infection at the time of starting the trial
• People who have a known HIV infection
• People who have active hepatitis B or hepatitis C infection
• People who have had another type of cancer within the past 5 years before the first dose
• People who still have unresolved side effects from previous cancer treatments
• People with a history of severe allergic reactions to ingredients in the study drug or to other monoclonal antibody medicines
• Women who are pregnant (confirmed by a test within 3 days before the first dose) or who are currently breastfeeding
• People who, in the opinion of the trial doctors, have any medical, psychological, or social condition that could affect their ability to consent, participate safely, or allow for accurate interpretation of results — including mental illness or substance or alcohol misuse

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