a study of bl-m17d1 in patients with locally advanced or metastatic her2 positive/negative breast cancer and other solid tumors

Conditions: Breast Cancer; Solid Tumor

Summary: this study is an open, multicenter, dose-escalation and expansion-enrollment nonrandomized phase i clinical study to evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of bl-m17d1 in patients with locally advanced or metastatic her2 positive/negative breast cancer and other solid tumors.


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 locally advanced or metastatic her2-positive/negative breast cancer and other solid tumors; 6. agree to provide archival tumor tissue samples or fresh tissue samples of 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. no blood transfusion is allowed within 14 days before the first use of the study drug, and no cell growth factor is allowed. the organ function level must meet the requirements; 12. coagulation function: international normalized ratio (inr) ≤1.5, and activated partial thromboplastin time (aptt) ≤1.5uln; 13. for premenopausal women of childbearing potential, a pregnancy test must be performed within 7 days before the initiation of treatment, serum pregnancy must be negative, and the patient must not be lactating; all enrolled patients (male or female) were advised to use adequate barrier contraception throughout the treatment cycle and for 6 months after the end 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, frequent and uncontrollable arrhythmia; 4. active autoimmune and inflammatory diseases; 5. other malignancies diagnosed within 5 years before the first dose; 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. a history of ild requiring steroid therapy, or current ild or radiation pneumonitis of grade ≥1 according to the rtog/eortc definition, or a suspicion of such disease; 9. patients with poor glycemic control; 10. complicated with pulmonary diseases leading to clinically severe respiratory function impairment; 11. patients with primary central nervous system tumors or cns metastases after failure of local treatment; 12. patients with a history of allergy to recombinant humanized antibody or human-mouse chimeric antibody or to any of bl-m17d1's excipients; 13. prior organ transplantation or allogeneic hematopoietic stem cell transplantation; 14. prior anthracycline therapy with more than the protocol-specified cumulative dose of an anthracycline; 15. human immunodeficiency virus antibody positive, active tuberculosis, active hepatitis b virus infection or active hepatitis c virus infection; 16. active infection requiring systemic therapy with a serious infection within 4 weeks prior to informed consent; there were indications of pulmonary infection or active pulmonary inflammation within 2 weeks before informed consent; 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; 19. pregnant or lactating women; 20. patients with superior vena cava syndrome should not be rehydrated; 21. a history of severe neurological or psychiatric illness; 22. severe unhealed wounds, ulcers, or fractures within 4 weeks before signing the informed consent; 23. subjects with clinically significant bleeding or obvious bleeding tendency within 4 weeks before signing the informed consent; 24. history of intestinal obstruction, inflammatory bowel disease or extensive bowel resection or presence of crohn's disease, ulcerative colitis or chronic diarrhea; 25. who are scheduled to receive live vaccine or who receive the vaccine within 28 days before the first dose; 26. the investigators did not consider it appropriate to apply other conditions for participation in the trial.