A Phase II Clinical Study to Evaluate the Efficacy and Safety of BL-B01D1 for Injection in Patients With Locally Advanced or Metastatic Chordoma
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.
• 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%;
• Organ function level must meet the requirements;
⁃ Coagulation function: international normalized ratio (INR) ≤1.5, and activated partial thromboplastin time (APTT) ≤1.5ULN;
⁃ Urine protein ≤2+ or \< 1000mg/24h;
⁃ 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.