Suncadia opens enrollment for SHR-1501 in BCG-unresponsive bladder cancer
The Phase 3 trial testing intravesical SHR-1501 plus BCG against chemotherapy moved to recruiting, with disease-free survival as the primary endpoint through 2030.
Executive Summary
- A Phase 3 trial testing SHR-1501, an IL-15 signaling activator, alongside BCG against chemotherapy in BCG-unresponsive bladder cancer moved from not-yet-recruiting to actively enrolling patients, with enrollment tracking to its original target.
- The trial addresses a population that has already failed standard intravesical therapy and faces bladder removal as the alternative, making disease-free survival on this design a test of whether an IL-15-based combination can stand in for surgery.
- The trial is the only Phase 3 program built on the IL-15 Receptor Complex in this indication, sitting alongside two earlier-stage IL-15 programs and a Phase 3 field otherwise built on different mechanisms.
- The launch shows no signs of instability: enrollment held at its planned level and the protocol has changed only once since the trial was first posted, a routine eligibility clarification.
The status change
The trial, registered as NCT07424287 and titled NiBladder 1, shifted status from Not yet recruiting to Recruiting on July 20, 2026, with a first patient start date of July 13, 2026. The randomized, open-label study plans to enroll 236 adults with BCG-unresponsive, high-risk non-muscle-invasive bladder cancer across sites in China, comparing intravesical SHR-1501 plus BCG against investigator-selected chemotherapy (options including epirubicin, pirarubicin, gemcitabine, hydroxycamptothecin, or mitomycin). The registered primary endpoint is disease-free survival assessed by blinded independent central review, measured over roughly five years, with overall survival, investigator-assessed disease-free survival, and adverse-event rates tracked as secondary measures. NCT07424287A Study of Intravesical SHR-1501 Combination With BCG Versus Investigator-selected Chemotherapy in Subjects With BCG-unresponsive NMIBCNCT07424287
Probability of SuccessBased on the AppliedXL Probability of Success model. For more information about the methodology, read the research here.
The clinical stake
Patients enrolled have already failed BCG, the standard intravesical immunotherapy for this disease, and the trial excludes those with muscle-invasive or metastatic disease, meaning the alternative for many is radical cystectomy. SHR-1501 is an IL-15 signaling activator, a class designed to stimulate immune cells directly within the bladder rather than relying on BCG's live-bacteria mechanism alone. Testing it in combination with BCG against a chemotherapy comparator sets up a direct read on whether stacking an IL-15-based immune activator onto BCG can extend disease-free survival past what chemotherapy achieves in a population with limited salvage options. NCT07424287A Study of Intravesical SHR-1501 Combination With BCG Versus Investigator-selected Chemotherapy in Subjects With BCG-unresponsive NMIBCNCT07424287
Competitive position
No other Phase 3 trial targets the IL-15 Receptor Complex in non-muscle-invasive bladder cancer, making SHR-1501 the only late-stage entrant built on this mechanism in this setting. The closest comparator by target and modality is ImmunityBio's nogapendekin alfa, an IL-15 superagonist combined with BCG in the same disease that has reached Phase 1/2. A second IL-15-pathway program, Novartis's NIZ985, and Nektar's avipendekin pegol remain in Phase 1 in other tumor types, so the mechanism itself has only early human testing behind it across indications. The broader Phase 3 field in this disease is built on different biology: Janssen's TAR-200, an intravesical drug-eluting system, and Suncadia's own SHR-A2102, a PD-L1-directed antibody-drug conjugate, are among the six Phase 3 programs recorded in the indication, none sharing SHR-1501's target.
Operational signal
The trial enrolled at its full anticipated target of 236, with no enrollment increase or reduction recorded since the study was first posted, a pattern the operational model treats as within the routine band. Since its first submission on February 13, 2026, the protocol has been amended once, narrowing the eligibility criteria to specify papillary-only, high-grade Ta or T1 disease without carcinoma in situ. That single change and the on-schedule move to recruiting carry no instability signal; the trial's primary completion date has not shifted from its original June 2030 target. NCT07424287A Study of Intravesical SHR-1501 Combination With BCG Versus Investigator-selected Chemotherapy in Subjects With BCG-unresponsive NMIBCNCT07424287
This analysis was produced using AI-assisted reporting systems, AppliedXL data, and official public records. These systems undergo editorial review, quality checks, and regular audits by human experts. Errors may still occur, as with any automated system. Always consult the linked primary sources. Read our AI Editorial Policy.