OncoMatch/Clinical Trials/NCT05957757
RC48 Combined With Tislelizumab for Bladder Sparing Treatment in NMIBC With BCG Treatment Failure and HER2 Expression
Is NCT05957757 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including RC48 and Tislelizumab for non-muscle invasive bladder cancer.
Treatment: RC48 · Tislelizumab — This is a prospective, open, single-center clinical study of anti-HER2-ADC combined with PD-1 monoclonal antibody for bladder sparing treatment in non-muscular invasive bladder cancer (NMIBC) patients with HER2-expressing. The study was conducted in accordance with the Good Clinical Practice (GCP). Approximately 20 subjects will be enrolled to evaluate the efficacy and safety of RC48 (RC48 2.0 mg/kg intravenously administered every two weeks) combined with Tislelizumab (Tislelizumab 200 mg intravenously administered every three weeks). Subjects undergo Transurethral resection of bladder tumor (TURBT), imaging diagnosis and pre-treatment biological samples of blood, urine and biopsy tissue. The study will include high-risk NMIBC patients who express HER2, fail after BCG treatment, but refuse to undergo cystectomy or do not meet the requirements for cystectomy. Subjects will receive RC48 and Tislelizumab for two years. BI-DFS were evaluated by cystoscopy, histopathologic examination, laboratory examination, and imaging examination after treatment, and tumor efficacy was evaluated when clinical studies reached the number of subjects specified in the protocol for efficacy evaluation.
Check if I qualifyExtracted eligibility criteria
Cancer type
Urothelial Carcinoma
Biomarker criteria
Required: HER2 (ERBB2) expression (detected by IHC)
the presence of HER2 expression was detected by IHC in the pathology department of our hospital
Disease stage
Required: Stage CIS
Excluded: Stage T2 OR HIGHER
Grade: high grade
Papillary carcinoma must be a high-risk disease defined as a high grade Ta/T1 lesion. CIS does not require complete excision, but must be completely excised with coexisting papillary carcinoma prior to enrollment
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: BCG therapy — non-muscle invasive bladder cancer
BCG treatment failure included no response to BCG treatment and relapse after inadequate BCG treatment
Cannot have received: anti-PD-1 therapy
Received other PD - 1 / PD - L1 inhibitor and/or HER2 inhibitor
Cannot have received: anti-PD-L1 therapy
Received other PD - 1 / PD - L1 inhibitor and/or HER2 inhibitor
Cannot have received: HER2-targeted therapy
Received other PD - 1 / PD - L1 inhibitor and/or HER2 inhibitor
Lab requirements
Blood counts
ANC ≥1,000/mm3; Platelet count ≥75,000/mm3; Hemoglobin ≥8.0g/dL (no blood transfusion and no G-CSF within 14 days before enrollment)
Kidney function
Creatinine clearance (CrCl) > 30 mL/min (Cockcroft-Gault formula)
Liver function
Total bilirubin ≤1.5× ULN or direct bilirubin ≤ULN for subjects with total bilirubin levels >1.5×ULN; ALT and AST ≤2.5× ULN; ≤1.5× ULN for patients not on anticoagulants
The major organs are functioning normally, the following criteria are met: ... see details above
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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