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

Suzhou Suncadia Biopharmaceuticals

Status and phase: Enrolling; Phase 3

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

Treatments: Drug: SHR-A1811 for Injection; Drug: Toripalimab Injection; Drug: Paclitaxel for Injection; Drug: SHR-1316 Injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT07111832

SHR-A1811-313

Details and patient eligibility

About

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).

Enrollment: 400 estimated patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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400 participants in 2 patient groups

SHR-A1811 and SHR-1316 Group

Experimental group

Treatment:

Drug: SHR-1316 Injection

Drug: SHR-A1811 for Injection

Toripalimab and Nab-paclitaxel Group

Active Comparator group

Treatment:

Drug: Paclitaxel for Injection

Drug: Toripalimab Injection