NCT06255964

A Study of IAP0971 in Combination With Bacillus Calmette Guerin in High Risk Non-muscular Invasive Bladder Cancer

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)

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 236 (estimated)
• Sponsor: SUNHO（China）BioPharmaceutical CO., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Bladder Cancer

Interventions

Type	Name	Description
DRUG	IAP0971	Induction 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
COMBINATION_PRODUCT	IAP0971＋BCG	Induction 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.
COMBINATION_PRODUCT	IAP0971＋BCG	Induction 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.

Timeline

• Start date: 2024-02-15
• Primary completion: 2024-10-07
• Completion: 2026-12-07
• First posted: 2024-02-13
• Last updated: 2024-02-13

Regulatory

• FDA-regulated drug study