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NCT Number: NCT06879145

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

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).

Recruiting

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

Location status: Recruiting

Location contact

Dingwei Ye

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 1.18-80 years old, gender not limited. 2.The patient voluntarily joined this study and signed informed consent 3.ECOG score is 0 or 1 4.Expected survival period ≥ 2 years. 5.Pathology and imaging diagnosis of non metastatic muscle invasive bladder cancer 6.There are assessable lesions that meet the RECIST 1.1 criteria 7. Enough organ function

Exclusion criteria

  • 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
  • There are clinical symptoms or diseases of the heart that have not been well controlled
  • Diagnosed with any other malignant tumor
  • Subjects who have experienced severe infections within 28 days prior to their first medication use
  • History of immunodeficiency
  • Use of attenuated live vaccine within 28 days prior to the first study medication
  • Have undergone major surgery within 28 days prior to the first administration of medication

Treatment and study plan

SHR-A2102;Adebrelimab

Drug

Treatment with SHR-A2102 in combination with fixed dose Adebrelimab

Primary outcomes

  1. Phase II: pCR evaluated by researchers;

    Time frame: Three months after the last subject underwent RC+PLD surgery

  2. Phase III: EFS assessed by BICR;

    Time frame: 5 years after the first medication of the last subject

Secondary outcomes

  1. ORR

    Time frame: from first dose to disease progression or death, whichever comes first, up to 3 years

  2. DCR

    Time frame: from first dose to disease progression or death, whichever comes first, up to 3 years

  3. pCR

    Time frame: Three months after MIBC surgery

  4. EFS

    Time frame: from first dose to disease progression or death, whichever comes first, up to 3 years

  5. DFS

    Time frame: from first dose to disease progression or death, whichever comes first, up to 3 years

  6. OS

    Time frame: from first dose to disease progression or death, whichever comes first, up to 3 years

  7. R0 resection rate

    Time frame: One month after the last subject underwent RC+PLD surgery

  8. AE

    Time frame: from Day1 to 90 days after last dose

Study contacts

Contact information is provided by the study sponsor or research team.

Xiaoxue Pi

CONTACT

[email protected]

0518-82342973

Sponsors and collaborators

Lead sponsor

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Industry

Registry information

Official study title

A Randomized, Open, Multicenter Phase II/III Clinical Study of SHR-A2102 for Injection Combined With Adebrelimab (SHR-1316) in Perioperative Treatment of Muscular Invasive Bladder Cancer (MIBC)

Important dates

Study start
2025
Primary completion
2031
Study completion
2031
First posted
Mar 17, 2025
Registry last updated
Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.