A Study of BL-B01D1 in Patients With Locally Advanced or Metastatic Chordoma

Launched by SICHUAN BAILI PHARMACEUTICAL CO., LTD. · Jan 16, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called BL-B01D1 for patients with locally advanced or metastatic chordoma, a rare type of bone cancer. The main goals of the study are to determine how safe the treatment is, how well it works, and how the body processes the drug. The trial is currently recruiting participants aged 18 to 75 who have been diagnosed with chordoma that cannot be surgically removed or has spread to other parts of the body. Eligible patients should also have a good level of overall health and meet specific medical criteria.

Participants in the trial will receive the BL-B01D1 injection and will be monitored closely by healthcare professionals throughout the study. They will need to sign a consent form and follow the study guidelines. It's important to note that certain individuals, such as those with severe heart or respiratory issues, recent infections, or other significant health problems, may not be eligible to join. Those who do participate will help researchers understand more about this treatment and its potential benefits for patients with chordoma.

Gender

ALL

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. Locally advanced (unresectable) or metastatic chordoma confirmed by histopathology;
• • 5. ECOG ≤2;
• • 6. The expected survival time as judged by the investigator was ≥3 months;
• • 7. The toxicity of previous antineoplastic therapy has returned to ≤ grade 1 as defined by NCI-CTCAE v5.0;
• • 8. No severe cardiac dysfunction, left ventricular ejection fraction ≥50%;
• • 9. Organ function level must meet the requirements;
• • 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 premenopausal women with childbearing potential, a pregnancy test must be performed within 7 days before starting treatment, a serum or urine pregnancy test must be negative, and the patient must not be lactating; All enrolled patients should take adequate barrier contraception during the entire treatment cycle and for 6 months after the end of treatment.
• Exclusion Criteria:
• • 1. Chemotherapy, biological therapy, immunotherapy, etc. within 4 weeks or 5 half-lives before the first dose, small molecule targeted therapy within 5 days, and palliative radiotherapy within 2 weeks;
• • 2. A history of central nervous system hemorrhage/infarction requiring treatment within 6 months before enrollment;
• • 3. History of severe heart disease and cerebrovascular disease;
• • 4. QT prolongation, complete left bundle branch block, III degree atrioventricular block, severe arrhythmia;
• • 5. Unstable thrombotic events requiring therapeutic intervention within 6 months before screening; Infusion-related thrombosis was excluded;
• • 6. Active autoimmune and inflammatory diseases;
• • 7. Other malignant tumors that progressed or required treatment within 5 years before the first dose;
• • 8. Poorly controlled hypertension (systolic blood pressure after adequate medical therapy \&gt; 150 mmHg or diastolic blood pressure \&gt; 100 mmHg);
• • 9. Poor glycemic control;
• • 10. Patients with a previous history of ILD requiring hormone therapy, or current ILD or ≥G2 radiation pneumonitis, or suspected to have such a condition during screening;
• • 11. Complicated with pulmonary diseases leading to clinically severe respiratory function impairment;
• • 12. Patients with a history of allergy to recombinant humanized or human-mouse chimeric antibodies or to any of the excipients of BL-B01D1;
• • 13. Received previous organ transplantation or allogeneic hematopoietic stem cell transplantation (Allo-HSCT);
• • 14. Human immunodeficiency virus antibody positive, active tuberculosis, active hepatitis B virus infection or active hepatitis C virus infection;
• • 15. Had a serious infection within 4 weeks before the first dose of study drug; Indications of active pulmonary infection within 2 weeks before the first dose of study drug;
• • 16. Imaging examination indicated that the tumor had invaded or enveloped the large blood vessels of the chest, neck, abdomen, ilium, and pharynx, except that the investigator thought that it would not affect the patient's medication;
• • 17. With a history of psychotropic drug abuse and inability to quit or a history of severe neurological or psychiatric illness;
• • 18. Serious unhealed wound, ulcer, or fracture within 4 weeks before signing the informed consent;
• • 19. Clinically significant bleeding or obvious bleeding tendency within 4 weeks before signing the informed consent;
• • 20. Patients scheduled for vaccination or receiving live vaccine within 28 days before the first dose;
• • 21. Had participated in another clinical trial within 4 weeks before the first dose;
• • 22. Other circumstances that the investigator deemed inappropriate for participation in the trial.