a study of bl-b16d1 in patients with unresectable locally advanced or metastatic breast cancer and other solid tumors

Conditions: Breast Cancer; Solid Tumor

Summary: this study is an open, multicenter, increasing dose and dose extension nonrandomized phase i clinical study to evaluate the safety, tolerability, pharmacokinetics characteristics and preliminary efficacy of bl-b16d1 in patients with unresectable locally advanced or metastatic breast cancer and other solid tumor.


Eligibility criteria:
inclusion criteria: 1. sign the informed consent form voluntarily and follow the protocol requirements; 2. gender is not limited; 3. age: ≥18 years old and ≤75 years old (stage ia); ≥18 years old (stage ib); 4. expected survival time ≥3 months; 5. patients with histologically and/or cytologically confirmed unresectable locally advanced or metastatic breast cancer and other solid tumors who failed or could not receive standard treatment; 6. consent to provide archival tumor tissue samples or fresh tissue samples from primary or metastatic lesions within 3 years; 7. must have at least one extracranial measurable lesion that meets the recist v1.1 definition; 8. ecog 0 or 1; 9. the toxicity of previous antineoplastic therapy has returned to ≤ grade 1 as defined by nci-ctcae v5.0; 10. no severe cardiac dysfunction, left ventricular ejection fraction ≥50%; 11. the organ function level must meet the requirements if the patient has not received blood transfusion or hematopoietic stimulation factor therapy within 14 days before the first dose; 12. coagulation function: international normalized ratio ≤1.5, and activated partial thromboplastin time ≤1.5uln; 13. urinary protein ≤2+ or ≤1000mg/24h; 14. for premenopausal women with childbearing potential, a pregnancy test must be performed within 7 days before starting treatment, serum pregnancy must be negative, and the patient must not be lactating; all enrolled patients (male or female) should use adequate contraception throughout the treatment cycle and for 6 months after completion of treatment. exclusion criteria: 1. chemotherapy, biological therapy and other anti-tumor therapies have been used within 4 weeks or 5 half-lives before the first dose; mitomycin and nitrosoureas were administered within 6 weeks before the first dose; oral drugs such as fluorouracil; 2. history of severe heart disease; 3. prolonged qt interval, complete left bundle branch block, iii degree atrioventricular block; 4. active autoimmune and inflammatory diseases; 5. patients with other malignant tumors or a history of other malignant tumors; 6. unstable thrombotic events requiring therapeutic intervention within 6 months before screening; infusion-related thrombosis was excluded; 7. hypertension poorly controlled by two antihypertensive drugs (systolic blood pressure \&gt; 150 mmhg or diastolic blood pressure \&gt; 100 mmhg); 8. patients with poor glycemic control; 9. patients with grade ≥1 radiation pneumonitis according to the rtog/eortc definition; previous history of ild or current ild, or suspicion of such disease during screening; 10. complicated with pulmonary diseases leading to clinically severe respiratory function impairment; 11. patients with primary central nervous system (cns) tumors or cns metastases that had failed local treatment; 12. patients with a history of allergy to recombinant humanized antibody or human-mouse chimeric antibody or to any of bl-b16d1's excipients; 13. received previous organ transplantation or allogeneic hematopoietic stem cell transplantation (allo-hsct); 14. in previous (new) adjuvant anthracyclines, the cumulative dose of anthracyclines for doxorubicin \> 550 mg/m2, epirubicin \> 900 mg/m2 or the equivalent dose of other similar drugs; 15. human immunodeficiency virus antibody positive, active tuberculosis, active hepatitis b virus infection or active hepatitis c virus infection; 16. serious infection occurred within 4 weeks before the first dose; signs of pulmonary infection or active pulmonary inflammation within 2 weeks before the first dose; 17. patients with massive or symptomatic effusions, or poorly controlled effusions; 18. had participated in another clinical trial within 4 weeks before the first dose (calculated from the time of the last dose); 19. had the following eye diseases: a. active infection or corneal ulcer; b. monocular vision; c. a history of corneal transplantation; d. contact lens dependence; e. uncontrolled glaucoma; f. uncontrolled or progressive retinopathy, wet macular degeneration, etc.; 20. other circumstances that the investigator deemed inappropriate for participation in the trial.