Spots Global Cancer Trial Database for A Study of IAP0971 in Combination With Bacillus Calmette Guerin in High Risk Non-muscular Invasive Bladder Cancer
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Trial Identification
Brief Title: A Study of IAP0971 in Combination With Bacillus Calmette Guerin in High Risk Non-muscular Invasive Bladder Cancer
Official Title: A Phase I/II Clincal Trial of Intravesical IAP0971 in Combination With Bacillus Calmette Guerin (BCG) in Patients With BCG Unresponsive High Risk Non-Muscular Invasive Bladder Cancer (NMIBC)
Study ID: NCT06255964
Conditions
Study Description
Brief 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.
Detailed 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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Contact Details
Name: ye dingwei, M.D.
Affiliation: Cancer Hospital affiliated to Fudan University
Role: PRINCIPAL_INVESTIGATOR
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