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Sarcoma, EwingPhase 2NCT05046314

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

A Phase 2 study testing TK216+Vincristin in people with Sarcoma, Ewing, run by Shanghai Pharmaceuticals Holding Co., Ltd at 8 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 14 years and older
Conditions the study is for
Sarcoma, Ewing
What is being tested?
TK216+Vincristin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
8 sitesChina
Study dates
12 Mar 2024to 5 Feb 2025
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 14 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Participants must meet all of the following inclusion criteria to be eligible for this study:
  • Willing to sign the informed consent form.
  • Participants with relapsed or refractory ES (including ESFT, except Ewing-like sarcoma) confirmed by cytohistology or molecular biology.
  • Life expectancy of at least 3 months.
  • Participants age ≥ 14 years, regardless of gender.
  • At least one measurable lesion according to RECIST version 1.1.
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  • Agree to have a central venous catheter in place prior to initiating infusion of study drug.
  • Prior radiotherapy is allowed if ≥ 2 weeks must have elapsed for local palliative external beam radiotherapy; ≥ 6 months must have elapsed if systemic radiotherapy, external craniospinal irradiation or > 50% pelvic radiotherapy; and ≥ 6 weeks must have elapsed for other substantial bone marrow radiotherapy before the first dose. Participants who have received brain radiotherapy must have completed whole brain radiotherapy and/or gamma knife surgery at least 4 weeks prior to enrollment.
  • Stem Cell Transplant or Rescue without TBI：no evidence of active graft-versus-host disease and ≥ 3 months must have elapsed since transplant.
  • Symptomatic CNS metastases must have been treated and remain stable for at least 4 weeks prior to the first dose of the study drug, or patients with asymptomatic brain metastases.
  • Adequate hematological and organ functions fulfilling the following laboratory requirements, and these results should be obtained within 7 days prior to the first dose:
  • ECOG performance score 0-2.
  • Cardiac ejection fraction ≥ 50% or shortening fraction ≥ 28%.
  • Eligible male and female participants of childbearing potential must consent to use reliable methods of contraception with their partners for at least 4 weeks before the start of protocol therapy, for the duration of study participation, and for at least 6 months after the last dose. Women of childbearing potential must have a negative blood pregnancy test within 7 days prior to the first dose.
  • Without any contraindication to vincristine.

Who cannot join

  • Participants will not be enrolled if they meet any of the following exclusion criteria:
  • Current participation in another therapeutic clinical trial.
  • 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.
  • Having received systemic corticosteroids or other systemic immunosuppressive agents within 14 days prior to study, with the following exceptions:
  • Topical, ocular, intra-articular, intranasal, or inhaled corticosteroids with minimal systemic absorption;
  • Short-term (≤ 7 days), prophylactic use of corticosteroids or for the treatment of non-autoimmune diseases
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  • Unresolved, > Grade 1 toxicity related to prior anti-tumor therapy prior to the study, according to the CTCAE version 5.0.
  • 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.
  • 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.
  • History of QTc prolongation
  • History of additional risk factors for torsades de pointes
  • 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.
  • 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.
  • Systemic use of antibiotics for ≥ 7 days within 4 weeks before TK216 treatment, or have fever of unknown origin (> 38.5 °C）
  • Positive test results for hepatitis B surface antigen, hepatitis C antibody and HIV antibody during screening.
  • Females who are pregnant or lactating.
  • 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.
  • 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.
  • Participants who are not suitable for participating in this study due to any reason as judged by the investigator.

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

China8 sites

  • Peking University People's Hospital

    Beijing, Beijing Municipality, 100044

  • Hunan Cancer Hospital

    Changsha, Hunan, 410031

  • The Second Affiliated Hospital Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310003

  • Shanghai Sixth People's Hospital

    Shanghai, Shanghai Municipality, 200233

  • Tianjin Medical University Cancer Institude & Hospital

    Tianjin, Tianjin Municipality, 300060

  • Union Hospital Tongji Medical College Huazhong University of Science and Technology

    Wuhan, Hubei, 100005

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450003

  • Henan Provincial People's Hospital

    Zhengzhou, Henan, 450003

Other trials in China

About this study

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

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).

Read the 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
Being tested
TK216+Vincristin
Keywords
Relapsed and refractory Ewing's Sarcoma
Medical subject headings
Sarcoma, Ewing, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TK216+VincristinBiological

    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.

Study groups in NCT05046314
Study groupRoleWhat they receive
TK216+VincristinExperimentalNot described
Receives: Biological: TK216+Vincristin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective Response Rate (IRC)

    Determination of the Objective Response Rate of all patients by IRC

    Measured: Up to 2 years after TK216 introduction

Secondary outcomes (7)

  1. Objective Response Rate (Investigator)

    Determination of the Objective Response Rate of all patients by investigators

    Measured: Up to 2 years after TK216 introduction

  2. Progression-free survival (PFS)

    Determination of the progression-free survival of all patients

    Measured: Up to 2 years after TK216 introduction

  3. Overall survival (OS)

    Determination of the overall survival times of all patients

    Measured: Up to 2 years after TK216 introduction

  4. Disease control rate (DCR)

    Determination of the disease control rate of all patients

    Measured: Up to 2 years after TK216 introduction

  5. Duration of remission (DOR)

    Determination of the duration of remission of all patients

    Measured: Up to 2 years after TK216 introduction

  6. Drug concentration in plasma

    Determination of drug concentration in plasma of all patients

    Measured: Up to 2 years after TK216 introduction

  7. Number of patients with adverse events

    Adverse event type, incidence, duration, correlation with study drug

    Measured: Up to 2 years after TK216 introduction

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Sep 2021
  2. Study start12 Mar 2024
  3. Primary completion5 Feb 2025
  4. Study completion5 Feb 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05046314
Sponsor's protocol ID
TK216-001
Status last verified
Dec 2025
First submitted
24 Aug 2021
Last updated
19 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing TK216+Vincristin in people with Sarcoma, Ewing, run by Shanghai Pharmaceuticals Holding Co., Ltd at 8 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (IRC) (time frame: Up to 2 years after TK216 introduction). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05046314.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2026.

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