A Phase 2 Multi Cohort Open Label Multi Center Clinical Study Evaluating the Efficacy and Safety of Disitamab Vedotin (RC48 ADC) Alone and in Combination with Pembrolizumab in Subjects with Locally Advanced Unresectable or Metastatic Urothelial Carcinoma That Expresses HER2

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Locally-advanced Unresectable Or Metastatic Urothelial Carcinoma
  • Age: Between 18 Year(s) - 100 Year(s)
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. Locally-advanced unresectable or metastatic UC with histopathological confirmation, including UC originating from the renal pelvis, ureters, bladder, or urethra
    2. Subjects must have received only 1 or 2 lines of prior systemic therapy for LA/mUC, including 1 line of platinum-containing chemotherapy
    3. Radiographically documented disease progression during or after the most recent line of therapy for LA/mUC

You may not be eligible for this study if the following are true:

    1. Known hypersensitivity to disitamab vedotin or any of their components
    2. Received antitumor treatment (including chemotherapy, radiotherapy, targeted therapy, immunotherapy, etc.) or participated in another clinical study within 2 weeks prior to the start of the study
    3. Prior MMAE-based ADCs (eg, enfortumab vedotin) or HER2-directed therapy



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