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 are at least 18 years old at the time of screening.
• People who have a confirmed diagnosis of recurring or metastatic head and neck squamous cell carcinoma (HNSCC), or another type of solid tumour, and whose cancer has gotten worse on standard treatments or who were unable to tolerate those treatments.
• People who have at least one tumour that can be measured using standard imaging criteria (called RECIST 1.1).
• People who agree to provide tumour tissue samples (either fresh or previously collected) and blood samples for the study.
• People who are reasonably active and able to care for themselves, rated 0 or 1 on a standard health performance scale (confirm with trial site).
• People who are expected to live for at least 12 weeks.
• People who agree to use effective contraception throughout the study.
• Women who are not pregnant and who either cannot become pregnant or have a confirmed negative pregnancy test at screening.
• People who have read, understood, and signed the informed consent form.

Who may not be able to join:

• People who have previously received or are currently receiving a treatment that targets a protein called B7-H3.
• People who have received certain chemotherapy, experimental drugs, or small-molecule targeted therapies within 14 days before the first planned dose.
• People who have received large-molecule anti-cancer drugs or other anti-cancer treatments within 28 days before the first planned dose.
• People who have had limited-area radiotherapy for symptom relief within 2 weeks, radiotherapy covering more than 30% of the bone marrow, or large-scale radiotherapy within 4 weeks before the first planned dose.
• People who have fluid build-up in the chest or abdomen requiring medical treatment, or fluid around the heart.
• People who have had major surgery within 4 weeks of the first planned dose.
• People who have cancer that has spread to the brain or is pressing on the spinal cord.
• People who are taking certain medications that strongly affect how the body processes drugs (specifically strong CYP3A4 inhibitors, inducers, or sensitive substrates with a narrow dosing range) within 7 days before the first dose, or who would need to take these during the study (confirm with trial site).
• People who are currently taking medications known to affect heart rhythm in a specific way (QT interval prolongation or risk of torsade de pointes), or who would need these during the study.
• People who still have significant side effects (Grade 2 or higher) from previous cancer treatments, with some exceptions such as stable thyroid problems managed with hormone therapy, hair loss, or nerve-related side effects.
• People who have a history of another separate primary cancer.
• People whose bone marrow, liver, kidneys, or other organs are not functioning well enough (confirm with trial site for specific thresholds).
• People who show signs of cardiovascular (heart and blood vessel) risk, or who have severe, uncontrolled, or active heart or blood vessel disease.
• People who have had a serious blood sugar crisis (diabetic ketoacidosis or hyperosmolar hyperglycaemia) within 6 months before the first dose, or whose long-term blood sugar control (HbA1c) is 7.5% or higher at screening.
• People who have severe or poorly controlled high blood pressure.
• People who have had significant or active bleeding within 1 month before the first planned dose.
• People who have had a serious blood clot in an artery or vein within 3 months before the first planned dose.
• People who have had a serious infection within 4 weeks before the first planned dose.
• People who have been on continuous steroid treatment for more than 30 days within the 30 days before the first dose, or who need long-term steroid use, or who have immune system deficiency conditions, or who have had an organ transplant.
• People with known active infectious diseases such as hepatitis B, hepatitis C, tuberculosis, syphilis, or HIV.
• People with serious liver conditions including hepatic encephalopathy, hepatorenal syndrome, or cirrhosis rated Child-Pugh Grade B or worse.
• People with moderate or severe lung diseases that could interfere with detecting or treating drug-related lung side effects, or that seriously affect breathing.
• People with a significant history of neurological or mental health conditions, including epilepsy, dementia, or severe depression, or any condition that could interfere with study assessments.
• Women who are breastfeeding, pregnant, or planning to become pregnant during the study.
• People who have received a vaccination or experienced any level of allergic reaction within 4 weeks before the first planned dose.
• People with a history of severe allergic reactions, severe reactions to infused treatments, or allergies to proteins derived from human or mouse sources.
• People who are allergic to any ingredient in the study drug HS-20093.
• People who, in the opinion of the study doctor, are unlikely to follow the study procedures and requirements.
• People who have any other disease or condition that, in the opinion of the study doctor, could put them at risk or interfere with the study.

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