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YY-20394

Phase 1

Small Lymphocytic Lymphoma | Small molecule | Oncology |Co-Diagnostics, Inc.|Last Updated: Jun 13, 2024

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 Enrollment43
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04279405A Phase Ib Study of YY-20394 in Participants With B-cell Hematologic MalignanciesPHASE1 COMPLETED 43Jun 15, 2020Jun 1, 2023Jun 13, 20241 China
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Study Endpoints
Primary Endpoints
Adverse events evaluated by NCI CTCAE V5.0
Throughout the study for approximately 2 years

incidence of adverse events and associated dose of YY-20394

Overall response rate
Throughout the study for approximately 2 years

the percentage of participants achieving a complete response or partial response

disease control rate
Throughout the study for approximately 2 years

the percentage of participants achieving a complete response or partial response or stable disease

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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
YY-20394EXPERIMENTALtreatment with YY-20394 will be continued until tumor progression or development of unacceptable toxicity.
Interventions
NameTypeDescription
YY-20394DRUGYY-20394 80mg tablet administered orally once daily
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * histologically or cytologically confirmed relapse and/or refractory B cell hematologic malignancies(Excluding follicular lymphoma) * prior treatment with ≥1 prior standard anti-tumor regimens and 2 courses of treatments at least * eastern cooperative oncology group performance...

Countries:China
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