a study of bl-m08d1 in patients with locally advanced or metastatic solid tumors

Conditions: 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-m08d1 for injection in 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 (phase ia); ≥18 years old (phase ib); 4. expected survival time ≥3 months; 5. locally advanced or metastatic solid tumors confirmed by histopathology and/or cytology that are incurable or currently have no standard treatment; 6. consent to provide archival tumor tissue samples or fresh tissue samples from primary or metastatic lesions within 2 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 (regardless of male or female) should use adequate barrier contraception during the whole treatment cycle and for 6 months after the end of treatment; 15. subjects were able and willing to comply with protocol-specified visits, treatment plans, laboratory tests, and other study-related procedures. 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. qt prolongation, complete left bundle branch block, iii degree atrioventricular block; 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 (systolic blood pressure \&gt; 150 mmhg or diastolic blood pressure \&gt; 100 mmhg); 7. history of ild requiring steroid therapy or current ild or ≥ grade 2 radiation pneumonitis; 8. complicated with pulmonary diseases leading to clinically severe respiratory function impairment; 9. had symptoms of active central nervous system metastasis; 10. patients with a history of allergy to recombinant humanized antibody or human-mouse chimeric antibody or to any of the ingredients of bl-m08d1; 11. received previous organ transplantation or allogeneic hematopoietic stem cell transplantation (allo-hsct); 12. human immunodeficiency virus antibody positive, active tuberculosis, active hepatitis b virus infection or active hepatitis c virus infection; 13. active infection requiring systemic therapy within 4 weeks before the first dose of study drug; 14. pleural, abdominal, pelvic or pericardial effusion requiring drainage and/or with symptoms within 4 weeks before the first dose of study drug; 15. received another trial drug 4 weeks or 5 half-lives before the first dose; 16. pregnant or lactating women; 17. the investigator did not consider it appropriate to apply other criteria for participation in the trial.