OncoMatch/Clinical Trials/NCT06187506
Disitamab Vedotin Combined With BCG Therapy in HER2-expressing High-risk Non-muscle Invasive Bladder Cancer
Is NCT06187506 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Disitamab vedotin and Bacillus Calmette Guerin Vaccine for non-muscle invasive bladder cancer.
Treatment: Disitamab vedotin · Bacillus Calmette Guerin Vaccine — This is a prospective, open, single-center clinical study of the anti-HER2(Human epidermal growth factor receptor-2) ADC(antibody-drug conjugate) drug Disitamab Vedotin in combination with BCG(bacillus Calmette-Guerin) therapy in very high-risk NMIBC(Non-muscle invasive bladder cancer) patients with HER2 expression (IHC 1+/2+/3+), which is being conducted in accordance with the Good Clinical Practice for Pharmaceutical Trials (GCP). Approximately 20 subjects will be enrolled in this study to evaluate the efficacy and safety of Disitamab Vedotin (2.0 mg/kg, administered intravenously every three weeks) in combination with BCG therapy.
Check if I qualifyExtracted eligibility criteria
Cancer type
Urothelial Carcinoma
Biomarker criteria
Required: HER2 (ERBB2) overexpression (ihc 1+/2+/3+)
Disease stage
Required: Stage TIS
Excluded: Stage III, IV, MUSCLE-INVASIVE, EXTRAVESICAL
Grade: HGG3
Confined to the mucosal (Ta, Tis) and lamina propria layers (T1) of the bladder. VHR(Very high risk) NMIBC, defined as having at least 1 of the following: Multiple and/or large (>3 cm) T1, (HG/G3) tumors; T1, (HG/G3) tumor with concurrent CIS; T1, G3 with CIS in prostatic urethra; Micropapillary variant of non-muscle invasive urothelial carcinoma
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: transurethral resection of bladder tumor — prior to first dose
all visible tumors removed as completely as possible prior to the first dose of study drug and documented at baseline cystoscopy
Cannot have received: anti-HER-2 therapy
Previously received other anti-HER-2 therapy
Lab requirements
Blood counts
adequate hematologic function
Kidney function
Creatinine clearance >=30 mL/min (Cockcroft-Gault formula)
Liver function
adequate end-organ function
Adequate hematologic and end-organ function, Creatinine clearance >=30 milliliters per minute (mL/min) (calculated using the Cockcroft-Gault formula)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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