a study of bl-b01d1+pd-1 monoclonal antibody in patients with unresectable locally advanced or recurrent metastatic triple-negative breast cancer

Conditions: Triple-negative Breast Cancer

Summary: this phase ii study is a clinical study to explore the efficacy and safety of bl-b01d1 combined with pd-1 monoclonal antibody in patients with unresectable locally advanced or recurrent metastatic triple-negative breast cancer.


Eligibility criteria:
inclusion criteria: 1. voluntarily sign the informed consent and follow the requirements of the protocol; 2. age: ≥18 years old and ≤75 years old; 3. expected survival time ≥3 months; 4. ecog 0 or 1; 5. subjects with histologically and/or cytologically confirmed, inoperable locally advanced or recurrent or metastatic triple-negative breast cancer; 6. patients should not have received previous systemic therapy for unresectable, locally advanced, recurrent, or metastatic triple-negative breast cancer; 7. a archived tumor tissue specimen or fresh tissue specimen of the primary or metastatic lesion within 2 years must be provided; 8. must have at least one place in accordance with recist v1.1 define measurable lesions; 9. no blood transfusion, no use of cell growth factors and/or platelet raising drugs within 14 days before screening, and the organ function level must meet the requirements; 10. toxicity of previous antineoplastic therapy has returned to ≤ grade 1 defined by nci-ctcae v5.0; 11. for premenopausal women with childbearing potential, a pregnancy test must be performed within 7 days before the initiation of treatment, the serum or urine pregnancy test must be negative, and the patient must not be lactating; all enrolled patients should take adequate barrier contraception during the entire treatment cycle and for 6 months after the end of treatment. exclusion criteria: 1. adc drugs that have received topoisomerase i inhibitors as small molecule toxins; 2. palliative radiotherapy within 2 weeks before the first dose; 3. patients with checkpoint inhibitors prior to neoadjuvant/adjuvant chemotherapy; 4. use of an immunomodulatory drug within 14 days before the first dose of study drug; 5. the history of severe cardiovascular and cerebrovascular diseases in the past six months was screened; 6. qt prolongation, complete left bundle branch block, iii degree atrioventricular block, frequent and uncontrollable arrhythmia; 7. active autoimmune and inflammatory diseases; 8. receiving long-term systemic corticosteroid therapy, etc., before the first dose; 9. other malignant tumors that progressed or required treatment within 5 years before the first dose; 10. presence of: a) poorly controlled diabetes mellitus before starting study treatment; b) severe complications associated with diabetes mellitus; c) a glycated hemoglobin level of 8% or more; d) hypertension poorly controlled by two antihypertensive drugs; e) history of hypertensive crisis or hypertensive encephalopathy; 11. present grade ≥2 radiation pneumonitis according to the rtog/eortc definition; patients with current ild; 12. complicated with pulmonary diseases leading to clinically severe respiratory impairment; 13. 6 months prior to screening needs treatment intervention unstable thrombotic events; 14. patients with active central nervous system metastases; 15. patients with massive or symptomatic effusions or poorly controlled effusions; 16. allergic history to recombinant humanized antibody or human-mouse chimeric antibody or allergic to any excipients of the test drug; 17. prior organ transplantation or allogeneic hematopoietic stem cell transplantation; 18. hiv antibody positive, active tuberculosis, active hepatitis b virus infection, or active hepatitis c virus infection; 19. serious infection within 4 weeks before the first dose of study drug; signs of pulmonary infection or active pulmonary inflammation within 4 weeks; 20. participated in another clinical trial within 4 weeks before the first dose; 21. patients with superior vena cava syndrome should not be rehydrated; 22. have a history of psychotropic substance abuse with an inability to quit or a history of severe neurological or psychiatric illness; 23. imaging examination showed that the tumor had invaded or wrapped the large thoracic vessels; 24. serious unhealed wound, ulcer, or fracture within 4 weeks before signing the informed consent; 25. clinically significant bleeding or obvious bleeding tendency within 4 weeks before signing the informed consent; 26. subjects who are scheduled to receive live vaccine or receive live vaccine within 28 days before the first dose; 27. other circumstances considered by the investigator to be inappropriate for participation in the trial.