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

ConditionLocally 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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • SHR-A2102 and Adebrelimab

    Drug

    SHR-A2102 and Adebrelimab injection

  • Gemcitabine and cisplatin / carboplatin

    Drug

    Gemcitabine injection and cisplatin injection / carboplatin injection

Treatment groups

453 Participants
are divided into 2 treatment groups
Group A: Treatment group 1Experimental treatment 1 intervention
Group B: Treatment group 3Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Progression-free survival(PFS), assessed by BICR

Time frame
up to 50 months

Secondary outcomes

1

Overall Survival(OS)

Time frame
up to 50 months
2

Objective response rate(ORR), assessed by BICR

Time frame
up to 50 months
3

Disease control rate(DCR), assessed by BICR

Time frame
up to 50 months
4

Duration of response(DoR), assessed by BICR

Time frame
up to 50 months

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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