Phase 2 Bladder 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 given voluntary written consent to take part in the study.
• Adults aged 18 or older, of any gender.
• People diagnosed with high-risk non-muscle-invasive bladder cancer (a type of bladder cancer that has not grown into the muscle wall) according to Chinese treatment guidelines (2022), which may or may not include carcinoma in situ (a very early form of cancer cells), and whose cancer falls into at least one of these categories: a stage T1 tumour of any grade; a high-grade tumour; or multiple and/or recurring tumours (not including a single low-grade recurring tumour).
• People whose bladder cancer tissue has been confirmed by laboratory testing to be mainly a type called uroepithelial carcinoma, with no spread into the muscle.
• People who have had a surgical procedure called TURBT (a surgery to remove bladder tumours) with all visible tumours removed within 3 weeks before starting the study treatment.
• People who have had imaging tests (including at least a CTU scan) within 3 months before joining, confirming the cancer has not spread to lymph nodes or other parts of the body.
• People who fit into one of two groups based on prior BCG treatment (a standard bladder cancer treatment): Group 1 — people with high-risk non-muscle-invasive bladder cancer who have not previously received BCG treatment, because they refused it, had a medical reason they could not have it, or BCG was not available to them; Group 2 — people whose cancer did not respond to BCG treatment, meaning the cancer came back or persisted within 12 months of completing an adequate course of BCG, or showed high-grade T1 disease after the initial BCG treatment phase (confirm details with trial site).
• People who have been assessed by a urologist as not suitable for bladder removal surgery, or who have chosen not to have bladder removal surgery.
• People whose tumour tissue (removed during TURBT within 3 weeks before starting the study) shows a certain level of a protein called HER2, measured as 1+, 2+, or 3+ on a standard laboratory test.
• People with a general health status score of 0–2 on the ECOG scale, meaning they are fully active, have some limitations but can care for themselves, or are up and about more than half the day (confirm with trial site).
• People whose heart, bone marrow, liver, and kidneys are functioning well enough to meet specific blood test results measured within 7 days before starting the study, including: heart pumping function of at least 50%; haemoglobin (a measure of red blood cells) of at least 9 g/dL; sufficient white blood cells and platelets; and liver and kidney test results within acceptable ranges (confirm exact values with trial site).
• Women who are surgically sterilised, post-menopausal, or who agree to use at least one medically approved form of contraception during the study and for 6 months after it ends, and who have a negative blood pregnancy test within 7 days before joining.
• Men who agree to use at least one medically approved form of contraception during the study and for 6 months after it ends.
• People who are willing and able to follow all trial procedures and attend follow-up appointments.

Who may not be able to join:

• People whose bladder cancer has grown into the muscle layer (stage T2 or higher), or whose cancer has spread to nearby lymph nodes or other parts of the body.
• People who also have uroepithelial carcinoma outside the bladder, such as in the urethra, ureters, or kidney.
• People who have received other cancer treatments — such as chemotherapy, radiation, targeted therapy, or immunotherapy — within 4 weeks before starting the study (one dose of chemotherapy given directly after TURBT is allowed as an exception).
• People who have not yet recovered from side effects of a previous cancer treatment to an acceptable level within 2 weeks before starting the study (confirm with trial site).
• People who have had major surgery within 4 weeks before starting the study, or who are expected to have major surgery during the trial.
• People who test positive for certain viral infections, including active hepatitis B, active hepatitis C, or HIV.
• People who have received a live vaccine within 4 weeks before starting the study, or who plan to receive any vaccine (other than a COVID-19 vaccine) during the study period.
• People with serious heart failure (classified as grade 3 or higher by a standard medical scale).
• People who have had a serious blood clot or cardiovascular event — such as a deep vein thrombosis, pulmonary embolism, stroke, brain bleed, or heart attack — within 6 months before starting the study (a small, symptom-free type of stroke that needed no treatment may be excepted — confirm with trial site).
• People with an active infection that requires treatment, such as active tuberculosis.
• People with serious or unstable ongoing health conditions that the study doctor considers a concern, including poorly controlled diabetes, high blood pressure, liver cirrhosis, lung conditions, or conditions that could make bladder treatment or anaesthesia unsafe.
• People with any other health condition, abnormal test result, or physical finding that the study doctor believes makes the study drug unsafe for them or would interfere with the study results.
• People with an active autoimmune disease (where the immune system attacks the body) that currently requires medication to suppress or regulate the immune system (certain hormone replacement therapies are allowed as an exception).
• People who have had another type of cancer within the past 5 years, with some exceptions: certain cancers that are considered fully treated (such as some thyroid cancers, early cervical cancer, certain skin cancers, or breast ductal carcinoma in situ treated with surgery); or certain cases of prostate cancer that meet specific criteria around stage, Gleason score, PSA levels, and disease stability (confirm with trial site).
• People who have previously had a bone marrow or stem cell transplant from a donor, or an organ transplant.
• People with a known allergy to the study drug (a HER2-targeted antibody-drug called recombinant humanised anti-HER2 monoclonal antibody-MMAE), gemcitabine, or any of their ingredients.
• Women who are pregnant or breastfeeding.
• People who the study team believes are unlikely to be able to follow the study requirements.

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