A Clinical Study of TK216 in Patients With Relapsed or Refractory Ewing's Sarcoma

Exclusion Criteria

• •1. Current participation in another therapeutic clinical trial.
• •2. Having received anti-tumor chemotherapy, targeted therapy or immunotherapy within 4 weeks prior to the first dose; having received Chinese herbal medicine or Chinese patent medicine-based therapies with definite anti-tumor indications within 3 weeks before study drug usage.
• •3. Having received systemic corticosteroids or other systemic immunosuppressive agents within 14 days prior to study, with the following exceptions:
• •1. Topical, ocular, intra-articular, intranasal, or inhaled corticosteroids with minimal systemic absorption;
• •2. Short-term (≤ 7 days), prophylactic use of corticosteroids or for the treatment of non-autoimmune diseases
• •4. Unresolved, \> Grade 1 toxicity related to prior anti-tumor therapy prior to the study, according to the CTCAE version 5.0.
• •5. History of previous cancer, except squamous cell or basal -cell carcinoma of the skin or any in situ carcinoma that has been completely resected, which required therapy within the previous 3 years.
• •6. Any of the following within 6 months: uncontrolled congestive heart failure (NYHA III-IV); uncontrolled angina; onset of cerebrovascular event or transient ischemic attack; pulmonary embolism; deep vein thrombosis and symptomatic bradycardia that require the use of antiarrhythmic drugs.
• •7. History of QTc prolongation
• •8. History of additional risk factors for torsades de pointes
• •9. Use of concomitant medications that may increase or possibly increase the risk to prolong the QTc interval and/or induce torsades de pointes ventricular arrhythmia.
• •10. Having received surgical therapies (except diagnostic surgery, such as tumor biopsy, diagnostic puncture, etc.), including surgical and interventional therapies, within 4 weeks prior to treatment.
• •11. Systemic use of antibiotics for ≥ 7 days within 4 weeks before TK216 treatment, or have fever of unknown origin (\> 38.5 °C）
• •12. Positive test results for hepatitis B surface antigen, hepatitis C antibody and HIV antibody during screening.
• •13. Females who are pregnant or lactating.
• •14. Have taken potent inducers or inhibitors of CYP3A4, potent inhibitors of CYP2C19 within 2 weeks prior to the first dose of study drug, or substrates of CYP3A4/CPY2C19 with a narrow therapeutic window.
• •15. Other severe acute or chronic medical or psychiatric conditions or laboratory abnormalities that may increase the risk associated with study participation or study drug management, or may interfere with the interpretation of the study results.
• •16. Participants who are not suitable for participating in this study due to any reason as judged by the investigator.