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ICP-022

Phase 2

Diffuse Large B Cell Lymphoma | Small molecule | Oncology |Co-Diagnostics, Inc.|Last Updated: May 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 Enrollment3
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04438005A Study of ICP-022 in Patients With R/R DLBCLPHASE2 COMPLETED 3May 7, 2020Dec 13, 2021May 13, 20247 China
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Study Endpoints
Primary Endpoints
Overall response rate(ORR)
Up to 3 years

The efficacy measured by overall response rate (ORR) according to the 2014 International Working Group NHL

Secondary Endpoints
Occurrence of adverse events and serious adverse events
Up to 3 years
Progression free survival(PFS)
Up to 3 years
Duration of response(DOR)
Up to 3 years
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
ICP-022EXPERIMENTAL -
Interventions
NameTypeDescription
ICP-022DRUGICP-022 is a white, round, uncoated tablet, 50 mg. It is administered orally at the dose of 150 mg/day from day 1 to day 28 of each cycle for up to a total of 6 cycles or until progression.
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites7

Key Inclusion criteria: 1. Men and women between 18 and 75 years old, 2. Histologically confirmed diffuse large B-cell lymphoma(DLBCL)with MyD88 L265P and CD79B positive, at least one measurable tumor of greater than 1.5 centimeter in long axis by contrast-enhanced CT/MRI, 3. ECOG performance statu...

Countries:China
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