NCT05046314

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

The Efficacy and Safety of TK216 in Subjects With Relapsed or Refractory Ewing's Sarcoma：a Phase II Clinical Trial in China

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Shanghai Pharmaceuticals Holding Co., Ltd · Industry
• Sex: All
• Age: 14 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

Ewing sarcoma is characterized by genomic rearrangements resulting in over-expression of ets family transcription factors driving tumor progression. TK216 is designed to inhibit this effect by inhibiting downstream effects of the EWS-FLI1 transcription factor. Based on USA RP2D result, designed as a single arm, multicenter open-label study，this study is the first study of TK216 in Chinese subjects with Ewing sarcoma. The study is designed to establish safety and efficacy data in combination with vincristine to assess the potential of TK216 for further development.

Conditions

• Sarcoma, Ewing

Interventions

Type	Name	Description
BIOLOGICAL	TK216+Vincristin	TK216 was continuously administered for 14 days，then rest for 14 days. Vincristin is given before TK216 only in the first day of each cycle, the first cycle of VCR is 0.75mg/m\^2 and 1.5mg/m\^2 from the second cycle，every 28 days is a study cycle.

Timeline

• Start date: 2024-03-12
• Primary completion: 2025-02-05
• Completion: 2025-02-05
• First posted: 2021-09-16
• Last updated: 2026-03-19

Locations

8 sites across 1 country: China