eligibility_summary
Adults ≥18 with high‑risk NMIBC (cTa/T1±CIS), urothelial, complete TURBT ≤3 wks, imaging ≤3 mos, unfit/refuse cystectomy, HER2 IHC 1+/2+/3+, ECOG 0–2, adequate organs, contraception, consent. Cohorts: BCG‑naive (refusal/CI/lack) or BCG‑non‑responsive after adequate BCG. Exclude MIBC/UTUC, recent anticancer therapy/major surgery, viral hepatitis/HIV or infection/vaccines, serious CV/TE, uncontrolled illness/autoimmunity, other malignancy, pregnancy.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Drugs/Interventions: RC48-ADC (disitamab vedotin), an anti-HER2 IgG1 antibody–drug conjugate carrying the microtubule inhibitor MMAE, plus intravesical gemcitabine, a nucleoside analog antimetabolite chemotherapy. Mechanisms: RC48-ADC binds HER2 on tumor cells, is internalized, and releases MMAE via a cleavable linker to inhibit tubulin polymerization, causing G2/M arrest and apoptosis, the IgG1 backbone may also trigger ADCC and a bystander effect. Gemcitabine inhibits ribonucleotide reductase and is incorporated into DNA, blocking DNA synthesis and inducing apoptosis, acting locally in the bladder. Targets: HER2/ERBB2-expressing urothelial carcinoma cells (IHC ≥1+), microtubule dynamics, and DNA replication pathways (ribonucleotide reductase, DNA polymerization) in proliferating NMIBC cells (BCG-naïve or BCG-unresponsive). Phase 2, single-arm.