NCT02657005

TK216 in Patients With Relapsed or Refractory Ewing Sarcoma

A Phase 1 / 2, Dose Escalation Study of Intravenous TK216 in Patients With Relapsed or Refractory Ewing Sarcoma

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 85 (actual)
• Sponsor: Oncternal Therapeutics, Inc · Industry
• Sex: All
• Age: 8 Years
• Healthy volunteers: Not accepted

Summary

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. This study is a first in human study of TK216 in subjects with Ewing sarcoma. The study is designed to establish initial safety and efficacy data in monotherapy and in combination with vincristine to assess the potential of TK216 for further development.

Detailed description

The study has been expanded to explore single agent TK216 for longer treatment duration. Approximately 26 patients will be enrolled in this Cohort. Please note: This study has been terminated and is no longer enrolling patients.

Conditions

• Sarcoma, Ewing

Interventions

Type	Name	Description
DRUG	TK216	Inhibitor of protein-protein interactions of EWS-FLI1 fusion protein

Timeline

• Start date: 2016-08-01
• Primary completion: 2022-05-01
• Completion: 2022-06-01
• First posted: 2016-01-15
• Last updated: 2025-02-12
• Results posted: 2024-11-07

Locations

9 sites across 1 country: United States