eligibility_summary
Adults ≥18 with recurrent NMIBC (high‑grade Ta/T1 and/or CIS, variants allowed), HER2+ by IHC, BCG‑unresponsive or relapse after inadequate BCG (per protocol), papillary tumors fully resected with appropriate cytology, refuse/unsuitable for cystectomy, ECOG 0–1, adequate organ function, consent, negative pregnancy test. Exclude T2+, small cell or pure squamous/adenoca CIS, prior PD‑1/PD‑L1/HER2 therapy, active malignancy, major CV/VTE/QTc>480, pregnancy, active HBV/HCV, uncontrolled HIV, unresolved AEs, poor wound healing, recent major surgery.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Single‑arm phase 2 trial in high‑risk NMIBC with HER2 expression after BCG failure tests RC48 (disitamab vedotin) plus tislelizumab for bladder‑sparing therapy. RC48 is an anti‑HER2 antibody‑drug conjugate (ADC) carrying MMAE, a microtubule inhibitor. It binds HER2 (ERBB2) on tumor cells, is internalized, and releases MMAE to disrupt microtubules and kill cancer cells, the antibody may also mediate ADCC and a bystander effect. Tislelizumab is a humanized IgG4 anti‑PD‑1 immune checkpoint inhibitor engineered to reduce FcγR binding, it blocks PD‑1/PD‑L1 signaling to restore cytotoxic T‑cell activity. Targets/pathways: HER2 on urothelial tumor cells, microtubules, PD‑1 on T cells and the PD‑1/PD‑L1 axis in the tumor microenvironment. Dosing: RC48 2.0 mg/kg IV q2w, tislelizumab 200 mg IV q3w, up to 2 years after TURBT.