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utidelone

Phase 2

HER-2 Negative Breast Cancer | Small molecule | Oncology |Co-Diagnostics, Inc.|Last Updated: Apr 16, 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 Enrollment79
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05398861Utidelone Combined With Bevacizumab in the Treatment of ≥ 2 Lines of HER-2 Negative Advanced Breast CancerPHASE2 RECRUITING 79Aug 19, 2022May 30, 2027Apr 16, 20261 China
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Study Endpoints
Primary Endpoints
Progression free survival (PFS)
up to 2 years

PFS is defined as the duration of time from first study treatment to disease progression or death from any cause as documented by the investigator

Secondary Endpoints
Objective response rate (ORR)
up to 2 years
Overall survival (OS)
up to 3 years
Duration Of Response(DOR)
up to 2 years
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
HER-2 Negative Advanced Breast CancerEXPERIMENTALUtidelone Combined with Bevacizumab
Interventions
NameTypeDescription
utidelone injectionDRUGUtidelone: 30 mg/m2/day, IV transfusing over 90 min. on day 1-day 5 of each 21 day cycle Bevacizumab:10mg/kg (IV), on day 1 of each 21 days.
BevacizumabDRUGBevacizumab: 10mg/kg, administered on day 1 of each cycle, with a treatment cycle lasting 21 days;
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Eligibility Criteria
Age Range18 Years — 70 Years
SexFEMALE
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Signed Informed Consent Form; 2. Women aged 18-70 years; 3. The number of treatment lines for patients ≥ 2 lines; 4. Histologically or cytologically confirmed HER2-negative locally advanced or metastatic breast cancer: 5. Patients with HER2-negative breast cancer who have fai...

Countries:China
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