NCT07393542
Recruiting
Phase 3
An Open Label, Randomized, Multicenter, Phase III Study of SHR-A2102 in Combination With Adebrelimab Versus Gemcitabine in Combination With Cisplatin/Carboplatin in Previously Untreated Locally Advanced or Metastatic Urothelial Carcinoma (NEC-UC2)
Suzhou Suncadia Biopharmaceuticals Co., Ltd.1 site in 1 country462 target enrollmentStarted: February 12, 2026Last updated:
Overview
- Phase
- Phase 3
- Status
- Recruiting
- Enrollment
- 462
- Locations
- 1
- Primary Endpoint
- Progression-free survival(PFS), assessed by BICR
Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
- •Expected survival of≥ 3 months.
- •Histologically confirmed diagnosis of urothelial carcinoma with radiographic or other confirmation of locally advanced unresectable or metastatic disease.
- •No prior systemic therapy for locally advanced or metastatic disease.
- •Able to provide archived or fresh tumor tissue for Nectin-4 and PD-L1 expression.
- •According to RECIST v1.1, there must be at least one measurable lesion;
- •Tolerant to cisplatin or carboplatin.
- •Adequate organ functions.
Exclusion Criteria
- •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.
- •Prior treatment with immune checkpoint inhibitors.
- •Major surgical procedure other than diagnostic or biopsy within 4 weeks, requiring elective surgery during the trial.
- •Active autoimmune disease requiring systemic treatment within 2 years.
- •Have experienced adverse events caused by previous anti-tumor treatments that have not recovered to grade ≤1 as per NCI-CTCAE v5.
- •Uncontrolled central nervous system metastases or carcinomatous meningitis.
- •Subjects with clinical symptoms or serous cavity effusion requiring puncture drainage.
Arms & Interventions
Treatment group 1
Experimental
SHR-A2102 and Adebrelimab
Intervention: SHR-A2102 and Adebrelimab (Drug)
Treatment group 2
Experimental
SHR-A2102 and Adebrelimab
Intervention: SHR-A2102 and Adebrelimab (Drug)
Treatment group 3
Active Comparator
Gemcitabine and cisplatin / carboplatin
Intervention: Gemcitabine and cisplatin / carboplatin (Drug)
Outcomes
Primary Outcomes
Progression-free survival(PFS), assessed by BICR
Time Frame: up to 50 months
Secondary Outcomes
- ORR, assessed by investigator(up to 50 months)
- DCR, assessed by investigator(up to 50 months)
- DoR, assessed by investigator(up to 50 months)
- Adverse event(AE)(up to 50 months)
- serious adverse event(SAE)(up to 50 months)
- Determine the dose of SHR-A2102 in the second phase, participants included in the dose selection analysis were followed up at 6 months in the last case(Determine the dose of SHR-A2102 in the second phase, participants included in the dose selection analysis were followed up at 6 months in the last case)
- Overall Survival(OS)(up to 50 months)
- Objective response rate(ORR), assessed by BICR(up to 50 months)
- Disease control rate(DCR), assessed by BICR(up to 50 months)
- Duration of response(DoR), assessed by BICR(up to 50 months)
- PFS, assessed by investigator(up to 50 months)
Investigators
Study Sites (1)
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