Clinical trialNCT02657005TerminatedPhase 1/PHASE2Interventional

TK216 in Patients With Relapsed or Refractory Ewing Sarcoma

SponsorOncternal Therapeutics, IncEnrollment85Sarcoma, Ewing

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

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Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

James Breitmeyer, MD
Oncternal Therapeutics
Study Director
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

9 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

Ucla Jonsson Comprehensive Cancer Center
Los Angeles, California, United States
Children'S Hospital of Colorado
Aurora, Colorado, United States
Children'S National Hospital
Washington D.C., District of Columbia, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Duke Cancer Institute
Durham, North Carolina, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Oregon Health & Science University
Portland, Oregon, United States
Texas Children'S Cancer & Hematology Centers, Baylor College
Houston, Texas, United States
Ut Md Anderson Cancer Center
Houston, Texas, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

TK216

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 31 Aug 2016
Primary completion: 31 May 2022
Completion: 30 Jun 2022
Last update posted: 12 Feb 2025
Registered enrollment: 85
Registry id: NCT02657005

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 4 Nov 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.