New drug shows promise for rare spine cancer
NCT ID NCT06787664
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests an experimental drug called BL-B01D1 in 27 adults with advanced chordoma, a rare bone cancer. The goal is to see if the drug can shrink tumors or slow disease progression. Participants receive the drug intravenously, and researchers monitor safety and effectiveness over time.
Why investors are watching
Sichuan Baili Pharmaceutical is testing its drug BL-B01D1 in a small phase II trial for chordoma, a rare cancer of the spine or skull base. For a small company, this readout matters because a positive result in an area with few treatment options could support further development and regulatory discussions. The trial enrolls only 27 participants, so the outcome will hinge on how many show disease control.
If it works: If BL-B01D1 shows meaningful disease control in chordoma, the company could advance the drug to a larger study or seek regulatory input. That result would give the company a new potential use for its drug beyond more common cancers.
If it fails: Phase II trials often fail to meet their goals, and a negative result here would set back this specific program. With only 27 patients, the study may also face delays in enrollment or produce results that are hard to interpret.
AI-written from the trial record. Speculative, and not investment advice.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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27 people
The number who actually took part.
- Started
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Jan 2025
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 \> 150 mmHg or diastolic blood pressure \> 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
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Other studies related to the condition(s) this trial covers.
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