# A Study of Intravesical SHR-1501 Combination With BCG Versus Investigator-selected Chemotherapy in Subjects With BCG-unresponsive NMIBC

Source: https://onco.cc/trials/nct07424287/  
OnCo record `nct07424287` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A phase 3 trial testing SHR-1501 in bladder & urothelial cancer, now recruiting.

## Summary

A Study of Intravesical SHR-1501 Combination With BCG Versus Investigator-selected Chemotherapy in Subjects With BCG-unresponsive NMIBC is a phase 3 interventional study registered as NCT07424287, led by Suzhou Suncadia Biopharmaceuticals, and recruiting on the registry. Official title: A Multicenter, Randomised, Open-label Phase III Clinical Study of Intravesical SHR-1501 Combined With Bacillus Calmette Guerin (BCG) Versus Investigator-selected Chemotherapy In Patients With BCG-unresponsive Papillary-Only Non-muscle-invasive Bladder Cancer (NMIBC) (NiBladder 1). Planned enrolment is 236 participants (estimated). The study started in 2026-07-13 and primary completion is expected in 2030-06. No results have been posted on ClinicalTrials.gov.

## Fields

- Kind: Trial
- Status: recruiting
- Last checked: 2026-09-11
- Also known as: NiBladder 1
- Tags: ctgov-ingest
- Registry id: NCT07424287
- Phase: 3
- Setting: A Multicenter, Randomized, Open-label Phase III Clinical Study of Intravesical SHR-1501 Combined With Bacillus Calmette Guerin (BCG) Versus Investigator-selected Chemotherapy In Patients With BCG-unresponsive Papillary-Only Non-muscle-invasive Bladder Cancer (NMIBC) (NiBladder 1)
- Sponsor: Suzhou Suncadia Biopharmaceuticals
- Enrolled: 236

## Sources

- ClinicalTrials.gov NCT07424287: https://clinicaltrials.gov/study/NCT07424287

## Connected records

- cancers: [Bladder & urothelial cancer](https://onco.cc/cancers/urothelial/), [Non-muscle-invasive bladder cancer](https://onco.cc/cancers/non-muscle-invasive-bladder-cancer/)
- drugs: [Pirarubicin](https://onco.cc/drugs/pirarubicin/), [SHR-1501](https://onco.cc/drugs/shr-1501/)
- companies: [Jiangsu Hengrui Pharmaceuticals](https://onco.cc/companies/hengrui/)

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