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

ConditionMuscular Invasive Bladder Cancer (MIBC)
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-80
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

This trial does not accept healthy volunteers

Qualifiers

None

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

Design model

Single group

Treatments tested in this trial

  • SHR-A2102；Adebrelimab

    Drug

    Treatment with SHR-A2102 in combination with fixed dose Adebrelimab

Treatment groups

840 Participants
are divided into 1 treatment group
Group A: Treatment with SHR-A2102 in combination with a fixed dose of AdebrelimabExperimental treatment 1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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