A Trial of SHR-A2102 With Adebrelimab in Locally Advanced or Metastatic Urothelial Carcinoma

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-80
SponsorSuzhou Suncadia Biopharmaceuticals Co., Ltd.

About this trial

The study is being conducted to evaluate the efficacy of SHR-A2102 with adebrelimab versus gemcitabine in combination with cisplatin/carboplatin in previously untreated locally advanced or metastatic urothelial carcinoma.

Eligibility criteria

Qualifiers

Be able to sign the informed consent form in writing.

Female or male, 18 to 80 years of age (both inclusive).

ECOG performance status of 0 or 1.

Expected survival of≥ 3 months.

Disqualifiers

Planned to receive any other anti-tumor therapy during the study.

Received other investigational products or treatments not yet marketed within 4 weeks.

Have received systemic anti-tumor treatment within 4 weeks;have received prior anti-tumor Chinese patent medicine treatment within 2 weeks; palliative radiotherapy or local therapy within 2 weeks.

Previously received therapy with an antibody-drug conjugate that meets any one of the following characteristics: targeting Nectin-4; containing irinotecan or its derivatives and acting as a topoisomerase I inhibitor.

Trial design

Treatments tested in this trial

  • SHR-A2102 and Adebrelimab
  • Gemcitabine and cisplatin / carboplatin

Treatment groups

462 Participants
are divided into 3 treatment groups