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TK216+Vincristin

Phase 2

Sarcoma, Ewing | Monoclonal antibody | Oncology |Co-Diagnostics, Inc.|Last Updated: Mar 19, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment15
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05046314A Clinical Study of TK216 in Patients With Relapsed or Refractory Ewing's SarcomaPHASE2 COMPLETED 15Mar 12, 2024Feb 5, 2025Mar 19, 20268 China
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Study Endpoints
Primary Endpoints
Objective Response Rate (IRC)
Up to 2 years after TK216 introduction

Determination of the Objective Response Rate of all patients by IRC

Secondary Endpoints
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
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
TK216+VincristinEXPERIMENTAL -
Interventions
NameTypeDescription
TK216+VincristinBIOLOGICALTK216 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.
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Eligibility Criteria
Age Range14 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites8

Inclusion Criteria: Participants must meet all of the following inclusion criteria to be eligible for this study: 1. Willing to sign the informed consent form. 2. Participants with relapsed or refractory ES (including ESFT, except Ewing-like sarcoma) confirmed by cytohistology or molecular biology...

Countries:China
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