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TGR-1202 + brentuximab vedotin

Phase 1

Hodgkin's Lymphoma | Small molecule | Oncology |TG Therapeutics, Inc.|Last Updated: Oct 2, 2019

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
UNCONTROLLEDDMC
Total Trials1
Total Enrollment16
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02164006Novel PI3K Delta Inhibitor TGR-1202, in Combination With Brentuximab Vedotin for Hodgkin's Lymphoma PatientsPHASE1 COMPLETED 16Jun 11, 2014May 1, 2016Oct 2, 20194 United States
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Study Endpoints
Primary Endpoints
Maximum Tolerated Dose acceptable for participants
21 days (1 cycle of therapy)

To determine the incidence of adverse events, any potential abnormal laboratory results and any dose-limiting toxicities

Secondary Endpoints
Overall Response Rate
Up to 1 year
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
TGR-1202 + brentuximab vedotinEXPERIMENTALTGR-1202 oral daily dose in combination with a fixed IV infusion of brentuximab vedotin
Interventions
NameTypeDescription
TGR-1202 + brentuximab vedotinDRUGTGR-1202 an oral daily dose with an IV infusion of brentuximab vedotin
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites4

Inclusion Criteria: * Confirmed diagnosis of Hodgkin's Lymphoma * Relapsed or refractory after an autologous stem cell transplant (ASCT) or at least two prior multi-agent chemotherapy regimens in patients not candidates for ASCT * Eastern Cooperative Oncology Group (ECOG) score of 0 to 2 Exclusion...

Countries:United States
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