Active — Not RecruitingPhase 2

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

China27 participantsStarted 2025-01-16

Plain-language summary

This is an open-label, multicenter phase II study to evaluate the safety, efficacy and pharmacokinetic characteristics of BL-B01D1 for Injection in patients with locally advanced or metastatic chordoma.

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓. Sign the informed consent form voluntarily and follow the protocol requirements;
✓. Gender is not limited;
✓. Age: ≥18 years old and ≤75 years old;
✓. Locally advanced (unresectable) or metastatic chordoma confirmed by histopathology;
✓. ECOG ≤2;
✓. The expected survival time as judged by the investigator was ≥3 months;
✓. The toxicity of previous antineoplastic therapy has returned to ≤ grade 1 as defined by NCI-CTCAE v5.0;
✓. No severe cardiac dysfunction, left ventricular ejection fraction ≥50%;

Exclusion criteria

✕. 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;
✕. A history of central nervous system hemorrhage/infarction requiring treatment within 6 months before enrollment;
✕. History of severe heart disease and cerebrovascular disease;
✕. QT prolongation, complete left bundle branch block, III degree atrioventricular block, severe arrhythmia;
✕. Unstable thrombotic events requiring therapeutic intervention within 6 months before screening; Infusion-related thrombosis was excluded;
✕. Active autoimmune and inflammatory diseases;
✕. Other malignant tumors that progressed or required treatment within 5 years before the first dose;
✕. Poorly controlled hypertension (systolic blood pressure after adequate medical therapy \> 150 mmHg or diastolic blood pressure \> 100 mmHg);

What they're measuring

Objective response rate (ORR)

Timeframe: Up to approximately 24 months

Trial details

NCT IDNCT06787664

SponsorSichuan Baili Pharmaceutical Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-06

View on ClinicalTrials.gov More Chordoma trials