The Efficacy and Safety of TK216 in Subjects With Relapsed or Refractory Ewing's Sarcoma：a Phase II Clinical Trial in China
This study is a multicenter, single-arm, open-label Phase II clinical trial evaluating TK216 in combination with vincristine in the treatment of relapsed or refractory Ewing sarcoma (ES) including Ewing's sarcoma family tumors (ESFTs).
‣ Participants must meet all of the following inclusion criteria to be eligible for this study:
• Willing to sign the informed consent form.
• Participants with relapsed or refractory ES (including ESFT, except Ewing-like sarcoma) confirmed by cytohistology or molecular biology.
• Life expectancy of at least 3 months.
• Participants age ≥ 14 years, regardless of gender.
• At least one measurable lesion according to RECIST version 1.1.
• Agree to have a central venous catheter in place prior to initiating infusion of study drug.
• Prior radiotherapy is allowed if ≥ 2 weeks must have elapsed for local palliative external beam radiotherapy; ≥ 6 months must have elapsed if systemic radiotherapy, external craniospinal irradiation or \> 50% pelvic radiotherapy; and ≥ 6 weeks must have elapsed for other substantial bone marrow radiotherapy before the first dose. Participants who have received brain radiotherapy must have completed whole brain radiotherapy and/or gamma knife surgery at least 4 weeks prior to enrollment.
• Stem Cell Transplant or Rescue without TBI：no evidence of active graft-versus-host disease and ≥ 3 months must have elapsed since transplant.
• Symptomatic CNS metastases must have been treated and remain stable for at least 4 weeks prior to the first dose of the study drug, or patients with asymptomatic brain metastases.
⁃ Adequate hematological and organ functions fulfilling the following laboratory requirements, and these results should be obtained within 7 days prior to the first dose:
⁃ ECOG performance score 0-2.
⁃ Cardiac ejection fraction ≥ 50% or shortening fraction ≥ 28%.
⁃ Eligible male and female participants of childbearing potential must consent to use reliable methods of contraception with their partners for at least 4 weeks before the start of protocol therapy, for the duration of study participation, and for at least 6 months after the last dose. Women of childbearing potential must have a negative blood pregnancy test within 7 days prior to the first dose.
⁃ Without any contraindication to vincristine.