Locally advanced or metastatic solid tumors that have failed standard treatment or for which standard treatment is unavailable.
Conditions
Interventions
Experimental group:Inject BL-M08D1
Sponsors
Fudan University Shanghai Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion 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 =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 =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
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 > 150 mmHg or diastolic blood pressure > 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety index;Efficacy indicators; | — |
Secondary
| Measure | Time frame |
|---|---|
| Immunogenic indicators;PK parameters:; | — |
Countries
China
Contacts
Public ContactWang Hongxia;Zhang Jian
Fudan University Shanghai Cancer Center
Outcome results
None listed