a study of bl-m05d1 in patients with locally advanced or metastatic solid tumors

Conditions: Locally Advanced or Metastatic Solid Tumors

Summary: this study is an open-label, multicenter, dose-escalation, and extended-enrollment nonrandomized phase i study to evaluate the safety, tolerability, pharmacokinetic characteristics, and preliminary efficacy of bl-m05d1 in patients with locally advanced or metastatic 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; 4. expected survival time ≥3 months; 5. locally advanced or metastatic solid tumors confirmed by histopathology and/or cytology with failure or intolerance to standard treatment or no standard treatment at present; 6. consent to provide archival tumor tissue samples or fresh tissue samples from primary or metastatic lesions within 3 years; 7. at least one measurable lesion meeting the recist v1.1 definition was required; 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, 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; 12. coagulation function: international normalized ratio (inr) ≤1.5, and activated partial thromboplastin time (aptt) ≤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) 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, immunotherapy 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 fluorouracil or palliative radiotherapy within 2 weeks before the first dose; chinese patent medicine within 2 weeks before the first administration; 2. history of severe cardiovascular and cerebrovascular diseases; 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 malignant tumors diagnosed within 5 years before the first dose; 6. hypertension poorly controlled by two antihypertensive drugs; 7. had a history of ild or a suspicion of such disease on imaging during screening; the patient was diagnosed with grade ≥1 radiation pneumonitis according to the rtog/eortc definition; 8. pulmonary disease defined as grade ≥2 according to ctcae v5.0; pulmonary diseases lead to clinically severe respiratory function impairment; 9. patients with poor glycemic control; 10. patients with active central nervous system metastases; 11. patients with massive or symptomatic effusions, or poorly controlled effusions; 12. imaging examination showed that the tumor had invaded or wrapped around the chest, neck, pharynx and other large blood vessels; 13. had a history of pulmonary embolism or a thrombotic event requiring therapeutic intervention within 6 months before screening; infusion-related thrombosis was excluded; 14. had a history of allergy to recombinant humanized antibody or human-mouse chimeric antibody or any of bl-m05d1 ingredients; 15. prior organ transplantation or allogeneic hematopoietic stem cell transplantation (allo-hsct); 16. the cumulative dose of anthracyclines \> 360 mg/m2 in previous (new) adjuvant therapy; 17. human immunodeficiency virus antibody positive, active tuberculosis, active hepatitis b virus infection or active hepatitis c virus infection; 18. active infection requiring systemic therapy; 19. had participated in another clinical trial within 4 weeks before the first dose; 20. pregnant or lactating women; 21. the investigator did not consider it appropriate to apply other criteria for participation in the trial.