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

NCT05046314 | Completed Phase 2

• 1 other identifier: TK216-001
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 8

Brief 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).

Conditions

Sarcoma, Ewing

Keywords

Relapsed and refractory Ewing's Sarcoma

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (IRC)

  Determination of the Objective Response Rate of all patients by IRC

  Up to 2 years after TK216 introduction

Secondary Outcomes (7)

• Objective Response Rate (Investigator)

  Up to 2 years after TK216 introduction

• Progression-free survival (PFS)

  Up to 2 years after TK216 introduction

• Overall survival (OS)

  Up to 2 years after TK216 introduction

• Disease control rate (DCR)

  Up to 2 years after TK216 introduction

• Duration of remission (DOR)

  Up to 2 years after TK216 introduction

Study Arms (1)

TK216+Vincristin

EXPERIMENTAL

Biological: TK216+Vincristin

Interventions

TK216+Vincristin BIOLOGICAL

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.

TK216+Vincristin

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Shanghai Pharmaceuticals Holding Co., Ltd: lead

Study Sites (8)

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

Location

Henan Cancer Hospital

Zhengzhou, Henan, 450003, China

Location

Henan Provincial People's Hospital

Zhengzhou, Henan, 450003, China

Location

Union Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, Hubei, 100005, China

Location

Hunan Cancer Hospital

Changsha, Hunan, 410031, China

Location

Shanghai Sixth People's Hospital

Shanghai, Shanghai Municipality, 200233, China

Location

Tianjin Medical University Cancer Institude & Hospital

Tianjin, Tianjin Municipality, 300060, China

Location

The Second Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310003, China

Location

MeSH Terms

Conditions

Sarcoma, Ewing; Recurrence

Condition Hierarchy (Ancestors)

Osteosarcoma; Neoplasms, Bone Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Yang Yao

  Shanghai 6th People's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2021
• First Posted: September 16, 2021
• Study Start: March 12, 2024
• Primary Completion: February 5, 2025
• Study Completion: February 5, 2025
• Last Updated: March 19, 2026

Record last verified: 2025-12

Locations

CN (8)