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YH004

Phase 1

Cancer | Small molecule | Oncology |Co-Diagnostics, Inc.|Last Updated: Sep 7, 2023

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
UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment8
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05040932Study of YH004 (4-1BB Agonist Antibody) in Advanced or Metastatic MalignancyPHASE1 COMPLETED 8Dec 7, 2021Jul 16, 2023Sep 7, 20233 Australia
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Study Endpoints
Primary Endpoints
Treatment-emergent adverse events (TEAEs) including determination of DLTs and serious AEs (SAEs)
up to 24 months

Adverse events will be assessed, and severity will be assigned by using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0

Maximum tolerated dose (MTD) and/or the recommended Phase II dose (RP2D)
up to 24 months

The MTD and/or RP2D will be determined based on TEAEs

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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
YH004EXPERIMENTALThe dose escalation phase includes 7 dose levels of YH004, and the highest dose is up to 10mg/kg. Route of administration is IV infusion, and the frequency of administration is once every 3 weeks (Q3W). one cycle is 3 weeks, and treatment can be up to 16 cycles if patients receive benefits.
Interventions
NameTypeDescription
YH004DRUGIV infusion once every 3 weeks (Q3W).
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Eligibility Criteria
Age Range18 Years — 80 Years
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: * Males or females aged 18 years to 80 years at the time of screening. * Ability to understand and willingness to sign a written informed consent document. * Subjects must have advanced histologically or cytologically confirmed solid tumor or relapsed or refractory Non-Hodgkin l...

Countries:Australia
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