study of adcs combined with adebrelimab in her2-negative advanced breast cancer

Conditions: Advanced Breast Cancer

Summary: our study is aimed to evaluate the efficacy and safety of novel adcs named shr-a1811 and shr-a1921 combined with adebrelimab in her2-negative advanced breast cancer.


Eligibility criteria:
inclusion criteria: 1. 18 years to 75 years old (including boundary values), female patients with breast cancer; 2. ecog ps score: 0\~1; 3. histologically or cytologically confirmed her2-negative advanced breast cancer; 4. disease progression after prior 1-2 lines of systemic therapy; if hr-positive, prior cdk4/6 inhibitor is necessary; 5. based on recist v1.1, at least one measurable lesion; 6. brain metastasis with no clinical symptoms, or treated, stable brain metastases are eligible; 7. no prior pd-(l)1 inhibitor; 8. patients must have a life expectancy ≥ 6 months; 9. adequate organ function and marrow function (no corrective treatment within 14 days before first dose); 10. patients of childbearing potential should have a negative urine or serum pregnancy, and must promise to use an adequate method of contraception starting with the first dose of study therapy through 6 months after the last dose of study therapy or be celibate; 11. available blood samples for ctdna detection in the exploratory study; 12. willing and able to provide written informed consent and comply with the requirements and restrictions in the protocol. exclusion criteria: 1. has known active brain metastasis which needs local therapy immediately; 2. prior anti-her2 or anti-trop-2 treatment; 3. has received or been receiving pd-(l)1 inhibitors and/or adc containing a topoisomerase inhibitor-like payload; 4. existence of third space fluid that is not well controlled by effective methods, e.g. drainage; 5. has received antitumor surgery, radiotherapy, chemotherapy, targeted therapy or immunological therapy within 4 weeks before first dose of study therapy; has received antitumor endocrine therapy within one week before first dose of study therapy; 6. use of other antitumor systemic treatment during the study; 7. has active autoimmune disease or a history of autoimmune disease; 8. known history of immunodeficiency, including hiv-positive, other acquired or innate immunodeficient disease, or known history of organ transplantation; 9. has active hepatitis b (hbsag-positive and hbv dna≥500 iu/ml), hepatitis c (positive for hcv antibody and hcv rna above uln) and hepatic cirrhosis; 10. has an active infection requiring antibiotics, antiviral or antifungal treatment, or pyrexia \>38.5℃ of unknown origin during the screening period before first dose of study therapy (patients with pyrexia due to cancer could be enrolled determined by investigator); 11. receiving immunosuppressive medication, or systemic corticosteroid therapy for the purpose of immunosuppression (prednisone at \>10mg/d or equivalent dose of other corticosteroids), and continuous use within 2 weeks before the first dose of study therapy; 12. other malignancy within prior 5 years unless curatively treated with no evidence of disease for at least recent 3 years, except: curatively treated in situ cancer of the cervix, skin basal cell carcinoma or skin squamous cell carcinoma; 13. hypersensitivity to study therapy or any of its excipients; 14. has known clinically significant lung disease, including but not limited to: interstitial lung disease, pneumonitis, pulmonary fibrosis; 15. known history of uncontrolled cardiovascular clinical symptom or disease that is not well controlled; 16. has received a live vaccine within 4 weeks before first dose of study therapy, or potential to receive a live vaccine during the trial treatment; 17. patients with a positive serum or urine pregnancy test or who are breastfeeding; patients of childbearing potential who are unwilling or not available to use an effective method of contraception; 18. other conditions that might influence the study and analysis of results in the opinion of the investigator.