The efficacy and safety of IAP0971 single drug or combined with BCG intravesical instillation in the treatment of high-risk non muscle invasive bladder cancer with BCG treatment failure.
Age ≥ 18 years on the day of signing informed consent form.
Patients who have NMIBC which is confirmed by cystoscopy, urine cytology and histopathology examination within 12 weeks prior to the first dose, and is classified as high risk according to the Guideline of Non-muscle Invasive Bladder Cancer issued by European Association of Urology (EAU) (version 2021)
CIS patients must have CIS on the tumor sample from the most recent cystoscopy/TURBT.
The most recent cystoscopy/TURBT must have been performed within 12 weeks prior to the first dose.
Patients who are known allergy or intolerance to investigational product, BCG or excipients.
Patients who have muscle-invasive bladder cancer (T2-T4) confirmed.
Patients who have concurrent extra-vesical (i.e., urethral, ureter or renal pelvis) non-muscle invasive transitional cell carcinoma of the urothelium.
Patients who have a history of vesicoureteral reflux.
Sequential
IAP0971
DrugInduction period (6 weeks): IAP0971 single drug bladder infusion, once a week;Maintenance period: IAP0971 single drug bladder infusion, performed at 3, 6, 12, 18, and 24 months, once a week, for 3 consecutive times
IAP0971＋BCG
Combination productInduction period (6 weeks): IAP0971 combined with BCG,Bladder perfusion, once a week;Maintenance period: IAP0971 combined with BCG bladder perfusion,Maintain at months 3, 6, 12, 18, and 24Perfusion, once a week, three times in a row.
IAP0971＋BCG
Combination productInduction period (6 weeks): IAP0971 combined with BCG,Bladder perfusion, once a week;Maintenance period: IAP0971 combined with BCG bladder irrigationNote, progress at months 3, 6, 12, 18, and 24Perform maintenance perfusion once a week, three times in a row.
DLTs occurrence
The DLT evaluation period is defined as 21 days after the first administration of investigational product.
MTD
During DLT evaluation period, if ≥2 cases DLTs occur in the 3 or 6 subjects in one dose group, the previous dose is defined as MTD.
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
