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The development of effective intravesical treatments for HER2\u2010expressing HR\u2010NMIBC is of great urgency. In this single\u2010arm phase I trial (ChiCTR2300073975), HER2\u2010expressing HR\u2010NMIBC patients received an induction course of weekly intravesical Disitamab vedotin (RC48) following a 3+3 design (60, 120, or 180\u00a0mg) for 6 weeks, followed by optional maintenance dose monthly for 11 sessions. The primary objective was to assess the safety and tolerability of intravesical RC48. The secondary objective was to determine the oncological outcomes. Between August 2023 and March 2024, nine patients were enrolled, and all completed the induction course without dose\u2010limiting toxicities (DLTs) or grade \u22653 drug\u2010related adverse events (AEs). The reported drug\u2010related AEs included urinary tract infection (55.6%, 5\/9), urinary frequency (11.1%, 1\/9), and hematuria (11.1%, 1\/9). The 6\u2010month and 12\u2010month recurrence\u2010free survival (RFS) rates were 100% (8\/8) and 87.5% (7\/8), respectively, whereas the progression\u2010free survival (PFS) rates were 100% (8\/8) and 100% (8\/8). Taken together, these findings indicate that intravesical RC48 was well tolerated and showed preliminary efficacy in HER2\u2010expressing HR\u2010NMIBC. 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