A Study of HS-10566 in Patients With High-risk Non-muscle-invasive Bladder Cancer Who Are Ineligi… (NCT07468851) | Clinical Trial Compass
Not Yet RecruitingPhase 1/2
A Study of HS-10566 in Patients With High-risk Non-muscle-invasive Bladder Cancer Who Are Ineligible for or Refuse Radical Cystectomy
China180 participantsStarted 2026-06-10
Plain-language summary
This is a multicenter, open-label, Phase I/II clinical study evaluating the safety, efficacy, tolerability, and pharmacokinetic/pharmacodynamic (PK/PD) profiles of HS-10566 in patients with high-risk non-muscle-invasive bladder cancer who are ineligible for or refuse radical cystectomy. The study comprises two distinct phases: a dose exploration phase and a proof-of-concept phase.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Men or women aged greater than or equal to (≥) 18 years.
✓. Signed informed consent form.
✓. Histologically confirmed non-muscle-invasive bladder urothelial carcinoma (i.e., transitional cell carcinoma). Mixed tumor types predominantly consisting of urothelial carcinoma are eligible. Patients diagnosed with neuroendocrine, micropapillary, signet-ring cell, plasmacytoid, or sarcomatoid features are excluded.
✓. Patients with non-muscle-invasive bladder cancer (NMIBC) who have undergone prior transurethral resection of bladder tumor (TURBT) and who refuse or are ineligible for radical cystectomy, and meet one of the following two populations:
✓. Patients who have not received BCG therapy after prior TURBT, including the following three scenarios:
✓. Participants must have undergone TURBT within 12 weeks prior to signing informed consent and meet the following criteria:
✓. For papillary lesions (Ta and T1 stages): complete resection of all visible papillary lesions, with negative urine cytology (including atypical findings).
Exclusion criteria
✕. Histopathologically confirmed muscle invasive (pathologic T stage ≥ T2), locally advanced, unresectable, or metastatic urothelial carcinoma.
What they're measuring
1
Phase I: RP2D
Timeframe: Up to 5 months
2
Phase II Arm 1: overall complete response (CR) rate
✕. Urothelial carcinoma outside the bladder (e.g., urethra, ureter, renal pelvis) unless radically resected with no disease recurrence for \> 2 years.
✕. History of other primary solid tumors, except:
✕. Radically treated solid tumor with no activity for ≥5 years before enrollment and low recurrence risk;
✕. adequately treated non-melanoma skin cancer (e.g., basal cell carcinoma, squamous cell carcinoma) or lentigo maligna with no evidence of recurrence;
✕. adequately treated carcinoma in situ (e.g., cervical, ductal carcinoma in situ of breast) with no evidence of recurrence.
✕. Has received or is receiving any of the following treatments:
✕. Regular intravesical chemotherapy (gemcitabine, pirarubicin, mitomycin, etc.) or BCG instillation intolerance following TURBT/bladder biopsy before enrollment.