Status:
UNKNOWN
A Phase Ib/II Study of SHR-A1811 Injection in Breast Cancer
Lead Sponsor:
Jiangsu HengRui Medicine Co., Ltd.
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-75 years
Phase:
PHASE2
Brief Summary
To evaluate the safety, tolerability and efficacy of SHR-A1811 in combination with pyrotinib or pertuzumab or adebrelimab or albumin-bound paclitaxel in patients with breast cancer.
Eligibility Criteria
Inclusion
- Women aged 18 to 75 (inclusive)
- Breast cancer confirmed by histology or cytology.
- ECOG score is 0 or 1
- An expected survival of ≥ 12 weeks
- At least one measurable lesion according to RECIST v1.1 criteria
- Have adequate renal and hepatic function
- Patients voluntarily joined the study and signed informed consent
Exclusion
- Have other malignancies within the past 5 years
- Active central nervous system metastasis without surgery or radiotherapy
- Presence with uncontrollable third space effusion
- Have undergone other anti-tumor treatment within 4 weeks before the first dose
- Immunosuppressant or systemic hormone therapy was used within 2 weeks prior to the first dose
- Any active autoimmune disease or a history of autoimmune disease
- A history of immune deficiency
- Clinically significant cardiovascular disorders
- Clinically significant history of lung disease
- The toxicity from previous anti-tumor treatment has not recovered to ≤ grade I
- Known hereditary or acquired bleeding tendency
- Active hepatitis and liver cirrhosis
- Presence of other serious physical or mental diseases or laboratory abnormalities
Key Trial Info
Start Date :
May 23 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
402 Patients enrolled
Trial Details
Trial ID
NCT05353361
Start Date
May 23 2022
End Date
December 31 2025
Last Update
September 15 2023
Active Locations (1)
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1
Jiangsu Provincial People's Hospital
Nanjing, Jiangsu, China, 210029