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Clinical Trial Summary

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.


Clinical Trial Description

Phase Ia study: for adults with BCG treatment failure or intolerance to BCG, high-risk non muscle invasive bladder cancerPatient, evaluate the safety and tolerability of IAP0971 monotherapy bladder infusion, and determine dose limiting toxicity and/or phase II recommended dose. Phase Ib study:To evaluate the safety and tolerability of intravesical IAP0971 in combination with BCG in patients with BCG unresponsive high risk non-muscle invasive bladder cancer, and to determine the DLT and RP2D. Phase II study:To evaluate the efficacy of intravesical IAP0971 in combination with BCG in patients with BCG unresponsive high risk NMIBC using RP2D as determined in the phase I study. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06255964
Study type Interventional
Source SUNHO(China)BioPharmaceutical CO., Ltd.
Contact wang xinshi, B.D.
Phone 15105183989
Email wangxinshi@sunho-bio.com
Status Not yet recruiting
Phase Phase 1/Phase 2
Start date February 15, 2024
Completion date December 7, 2026

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