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Clinical Trials in China / NCT07111832
Recruiting Phase 3

A Clinical Trial of SHR-A1811 in the Treatment of Triple-negative Breast Cancer

NCT07111832 · tracked via the Priya Life Science China tracker
Sponsor
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Phase
Phase 3
Started
2025-08-20
Last updated
2025-12-18

Condition(s) studied

PD-L1-positive Locally Recurrent Unresectable or Metastatic Triple-negative Breast Cancer

Investigational drug(s) / intervention(s)

SHR-A1811 for InjectionSHR-1316 InjectionToripalimab InjectionPaclitaxel for Injection

SHR-A1811 for Injection: SHR-A1811 for injection.

SHR-1316 Injection: SHR-1316 injection.

Toripalimab Injection: Toripalimab injection.

Paclitaxel for Injection: Paclitaxel for injection.

Study summary

This study is to evaluate the progression-free survival (PFS) of SHR-A1811 combined with SHR-1316 in the first-line treatment of PD-L1-positive locally recurrent unresectable or metastatic triple-negative breast cancer with Toripalimab combined with Nab-paclitaxel, as assessed by blinded independent central review (BICR).

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: 1. Age 18-75 years old (including both ends), female. 2. Pathologically confirmed locally recurrent unresectable or metastatic triple-negative breast cancer. 3. Expected survival ≥ 12 weeks. 4. Have adequate renal and hepatic function. 5. Patients voluntarily joined the study and signed the informed consent. Exclusion Criteria: 1. Patients with active central nervous system (CNS) metastases who have not undergone surgery or radiotherapy. 2. Have other malignancies within the past 5 years. 3. Presence with uncontrollable third space effusion. 4. Have undergone other anti-tumor treatment within 4 weeks before the first dose. 5. A history of immunodeficiency. 6. Clinically significant cardiovascular diseases. 7. Known or suspected interstitial lung disease. 8. Known hereditary or acquired bleeding tendency. 9. Toxicities from prior anti-tumor therapy that have not recovered to ≤ Grade 1. 10. Known hypersensitivity to any of the study drugs or their excipients, or a history of allergy to humanized monoclonal antibody products. 11. Presence of other severe physical or mental disorders or clinically significant laboratory abnormalities.

Primary outcome measure(s)

Trial sites (2)

FacilityCityRegionStatus
Peking University Cancer Hospital Beijing Beijing Municipality Recruiting
Cancer Hospital,Fudan University Shanghai Shanghai Municipality Recruiting

More Suzhou Suncadia Biopharmaceuticals Co., Ltd. trials in China

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07111832 on ClinicalTrials.gov ↗ ← All trials in China