ClinicalTrialsFinder
RecruitingPhase 3NCT07111832

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

A Phase III, Multicenter, Randomized, Open-label, Active-controlled Study of SHR-A1811 Plus SHR-1316 Versus Toripalimab Plus Nab-paclitaxel in PD-L1-positive Locally Recurrent Unresectable or Metastatic Triple-negative Breast Cancer

Sponsor

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Enrollment

400 participants

Start Date

Aug 20, 2025

Study Type

INTERVENTIONAL

Conditions

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

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: FEMALEMin Age: 18 YearsMax Age: 75 Years

Inclusion Criteria5

  • Age 18-75 years old (including both ends), female.
  • Pathologically confirmed locally recurrent unresectable or metastatic triple-negative breast cancer.
  • Expected survival ≥ 12 weeks.
  • Have adequate renal and hepatic function.
  • Patients voluntarily joined the study and signed the informed consent.

Exclusion Criteria11

  • Patients with active central nervous system (CNS) metastases who have not undergone surgery or radiotherapy.
  • Have other malignancies within the past 5 years.
  • Presence with uncontrollable third space effusion.
  • Have undergone other anti-tumor treatment within 4 weeks before the first dose.
  • A history of immunodeficiency.
  • Clinically significant cardiovascular diseases.
  • Known or suspected interstitial lung disease.
  • Known hereditary or acquired bleeding tendency.
  • Toxicities from prior anti-tumor therapy that have not recovered to ≤ Grade 1.
  • Known hypersensitivity to any of the study drugs or their excipients, or a history of allergy to humanized monoclonal antibody products.
  • Presence of other severe physical or mental disorders or clinically significant laboratory abnormalities.

Interventions

DRUGSHR-A1811 for Injection

SHR-A1811 for injection.

DRUGSHR-1316 Injection

SHR-1316 injection.

DRUGToripalimab Injection

Toripalimab injection.

DRUGPaclitaxel for Injection

Paclitaxel for injection.

Locations(2)

Peking University Cancer Hospital

Beijing, Beijing Municipality, China

Cancer Hospital，Fudan University

Shanghai, Shanghai Municipality, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07111832