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SHR-A1811 for Injection

DRUG5 trials

Sponsors

Henan Cancer Hospital, Suzhou Suncadia Biopharmaceuticals Co., Ltd., Jiangsu HengRui Medicine Co., Ltd.

Conditions

Early-stage or Locally Advanced HER2-positive Breast CancerGastric CancerGastroesophageal-junction CancerHER2 Low Breast CarcinomaPD-L1-positive Locally Recurrent Unresectable or Metastatic Triple-negative Breast CancerSolid Tumor

Phase 1

A Clinical Study of SHR-A1811(sc) Subcutaneous Injection in Patients With Solid Tumor
RecruitingNCT07275242
Suzhou Suncadia Biopharmaceuticals Co., Ltd.Solid Tumor
Start: 2025-12-23End: 2027-12-31Target: 107Updated: 2026-01-15

Phase 2

A Study of SHR-A1811 as Neoadjuvant Treatment for Patients With HR-Positive, Low HER2 Expression Breast Cancer
RecruitingNCT05911958
Henan Cancer HospitalHER2 Low Breast Carcinoma
Start: 2023-07-05End: 2029-05-31Target: 66Updated: 2024-11-04
A Trial of Adebrelimab Plus (SHR-A1811/SHR-A1904 With Chemotherapy) or SHR-8068 as Treatment for Gastric/GEJ Cancer
RecruitingNCT07110571
Suzhou Suncadia Biopharmaceuticals Co., Ltd.Gastric Cancer, Gastroesophageal-junction Cancer
Start: 2025-08-28End: 2027-05-31Target: 200Updated: 2026-01-09

Phase 3

A Clinical Trial of SHR-A1811 in the Treatment of Triple-negative Breast Cancer
RecruitingNCT07111832
Suzhou Suncadia Biopharmaceuticals Co., Ltd.PD-L1-positive Locally Recurrent Unresectable or Metastatic Triple-negative Breast Cancer
Start: 2025-08-20End: 2028-12-31Target: 400Updated: 2025-12-18
A Trial of SHR-A1811 Compared to Other Antitumor Therapies as Neoadjuvant Treatments in Early-stage or Locally Advanced HER2-positive Breast Cancer
RecruitingNCT07196774
Jiangsu HengRui Medicine Co., Ltd.Early-stage or Locally Advanced HER2-positive Breast Cancer
Start: 2025-10-23End: 2028-12-01Target: 740Updated: 2026-01-30

Related Papers

Abstract PS3-07: SHR-A1811 as Neoadjuvant Treatment in Patients with HR-Positive, HER2-low Breast Cancer: The first-stage results from an open-label, single-arm, two-stage, phase II clinical trial
Clinical Cancer Research2025-06-131 citations
SHR-A1811 as neoadjuvant therapy for HR-positive, HER2-low breast cancer: A single-arm, phase II clinical study.
Journal of Clinical Oncology2025-05-281 citations