Patients with pathologically confirmed locally advanced (non resectable) or metastatic chordoma
Conditions
Interventions
Experimental group:This study will explore at two dose levels:
(1) BL-B0ID1 2.5mg/kg D1D8 Q3W
(2) BL-B01D12.2mg/kg D1D8 Q3W
The research drug BL-B01D1 is administered via intravenous drip, with D1 and D8 being administered in a 3-week cycle. The first intravenous infusion lasts for 120min+/-10min. If the infusion reaction
After the disease progression of the study participants, the researchers evaluated that continuing treatment would be beneficial for the study participants, and the study participants were also willin
Sponsors
Sun Yat-sen University Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. voluntarily sign the informed consent and follow the protocol requirements; 2. unlimited gender; 3. age: >= 18 and = 3 months; 7. the toxicity of previous anti-tumor treatment has returned to grade = 90g/l); 8. no serious cardiac dysfunction, left ventricular ejection fraction >= 50%; 9. organ function level must meet the following requirements and standards: a. Bone marrow function: absolute neutrophil count (ANC) >= 1.5 × 10^9/l, platelet count >= 100 × 10^9/l, hemoglobin >= 90 g/l without receiving blood transfusion and hematopoietic stimulating factor treatment within 14 days before the first administration;b. Liver function: total bilirubin (TBIL = 50 ml/min (according to Cockcroft and Gault formula, see Appendix 5), urinary protein <= 2+ or <= 1000mg/24h (urine); 10. coagulation function: international normalized ratio (INR) <= 1.5, and activated partial thromboplastin time (APTT) <= 1.5uln; 11. urine protein <= 2+ or < 1000mg/24h; 12.For women with childbearing potential before menopause, pregnancy test must be done within 7 days before starting treatment. Serum or urine pregnancy test must be negative and must be non lactation;All enrolled patients should take adequate barrier contraceptive measures throughout the treatment cycle and 6 months after the end of treatment.
Exclusion criteria
Exclusion criteria: 1. used chemotherapy, biological therapy, immunotherapy, radical radiotherapy, major surgery, large-area radiotherapy (more than 30% bone marrow radiotherapy or carried out large-area radiotherapy) within 4 weeks or 5 half lives before the first administration (whichever is shorter), used small molecule targeted therapy (including small molecule tyrosine kinase inhibitors) within 5 days, used palliative radiotherapy within 2 weeks (but palliative radiotherapy is allowed for bone lesions), nmpa has approved the listing of modern traditional Chinese medicine for anti-tumor treatment and other anti-tumor treatments; 2. a history of CNS hemorrhage / infarction requiring treatment, such as stroke or intracerebral hemorrhage (including embolic stroke), within 6 months before enrollment; 3. history of serious heart disease and cerebrovascular disease, such as New York Heart Association (NYHA) >= grade 2 heart failure, acute coronary syndrome (such as myocardial infarction, unstable angina pectoris, etc.) within 6 months before screening, acute cerebrovascular disease (such as transient ischemic attack, cerebral infarction, cerebral hemorrhage, etc.) within 6 months before screening, etc; 4. QT interval prolongation (QTc > 450 msec in men or QTc > 470 msec in women), complete left bundle branch block, degree III atrioventricular block, severe arrhythmia (except for 2 weeks after treatment with antiarrhythmic drugs); 5. unstable deep vein thrombosis, arterial thrombosis, pulmonary embolism and other thrombotic events requiring therapeutic intervention within 6 months before screening; Except for infusion set related thrombosis. 6. active autoimmune diseases and inflammatory diseases, such as systemic lupus erythematosus, psoriasis requiring systemic treatment, rheumatoid arthritis, inflammatory intestinal diseases, etc., except for type I diabetes, hypothyroidism that can be controlled by only alternative treatment, and skin diseases that do not require systemic treatment (such as vitiligo and psoriasis); 7. there are other malignant tumors that have progressed or need treatment within 5 years before the first administration, with the following exceptions: skin basal cell carcinoma, skin squamous cell carcinoma, breast ductal carcinoma in situ, papillary thyroid carcinoma, superficial bladder cancer, etc. that have undergone radical treatment; 8. poorly controlled hypertension (systolic blood pressure >150 mmHg or diastolic blood pressure >100 mmHg after adequate drug treatment); 9. poor blood glucose control (defined as: a) twice fasting blood glucose > 10mmol/l, or b) glycated hemoglobin level reaching more than 8%), or accompanied by diabetic gangrene; 10. patients with previous history of interstitial lung disease (ILD) requiring hormone therapy (including pulmonary fibrosis, etc.), or current patients with ILD or >= G2 radiation pneumonitis, or suspected of having such disease through imaging examination during screening; 11. complicated with pulmonary disease resulting in clinically severe impairment of respiratory function, including but not limited to the following: A. any underlying pulmonary disease (for example, pulmonary embolism, severe asthma, severe chronic obstructive pulmonary disease within 3 months before randomization), B. restrictive pulmonary disease; c. One side pneumonectomy was performed in the past. 12. patients with a history of allergy to recombinant humanized antibody or human mouse chimeric antibody or allergic to a
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate;Disease control rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival;Duration of mitigation;Adverse events during treatment; | — |
Countries
China
Contacts
Public ContactJiang Xiaobin
Sun Yat-sen University Cancer Center (Sun Yat-sen University Affiliated Cancer Hospital, Sun Yat-sen University Cancer Institute)
Outcome results
None listed