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.
The study is currently in the "expansion" phase after finding the recommended phase 2 dose in the dose/schedule escalation cohorts. Eighteen patients will be enrolled in the expansion phase. Vincristine is administered starting cycle 1, along with a 14 day continuous infusion of TK216.
|Clinical Study Identifier||NCT02657005|
|Sponsor||Oncternal Therapeutics, Inc|
|Last Modified on||21 September 2020|
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