Clinical Study on the Treatment of MIBC Patients With SHR-A2102 Injection Combined With Adebrelimab (SHR-1316)

Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorSuzhou Suncadia Biopharmaceuticals Co., Ltd.

About this trial

In phase II, the main objective is to evaluate the efficacy of SHR-A2102 combined with Adebrelimab in the treatment of muscular invasive bladder cancer (MIBC); The main objective of phase III is to evaluate the efficacy of SHR-A2102 for injection combined with Adebrelimab compared with gemcitabine combined with cisplatin in the treatment of muscular invasive bladder cancer (MIBC).

Eligibility criteria

Qualifiers

Age over 18 years old, gender not limited.

The patient voluntarily joined this study and signed informed consent

ECOG score is 0 or 1

Expected survival period ≥ 2 years.

Disqualifiers

Received systemic anti-tumor therapy 4 weeks before starting the study treatment

The toxicity and/or complications of previous anti-tumor treatments have not recovered to NCI-CTCAE ≤ 1 level

Subjects known or suspected to have interstitial pneumonia

Individuals with any active, known or suspected autoimmune diseases

Trial design

Treatments tested in this trial

  • SHR-A2102;Adebrelimab

Treatment groups

840 Participants
are divided into 1 treatment group