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

NCT06255964 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 236

Last updated 2024-02-13

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • SUNHO（China）BioPharmaceutical CO., Ltd.

    lead INDUSTRY

Principal Investigators

  • ye dingwei, M.D. · Cancer Hospital affiliated to Fudan University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-15
Primary Completion
2024-10-07
Completion
2026-12-07
FDA Drug
Yes

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06255964 on ClinicalTrials.gov