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Hu5F9-G4

Phase 1

Solid Tumor | Small molecule | Oncology |Gilead Sciences, Inc.|Last Updated: Feb 5, 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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment88
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02216409Phase 1 Trial of Hu5F9-G4, a CD47-targeting AntibodyPHASE1 COMPLETED 88Aug 1, 2014Dec 1, 2018Feb 5, 20196 United States
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Study Endpoints
Primary Endpoints
Safety and Tolerability of Hu5F9-G4
The first 28 days on study, for determination of Dose Limiting Toxicities

The CTCAE criteria will be used to assess adverse events on this trial.

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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Treatment (Hu5F9-G4)EXPERIMENTALHu5F9-G4 monotherapy
Interventions
NameTypeDescription
Hu5F9-G4DRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites6

Inclusion Criteria: Patients with histologically or cytologically confirmed advanced solid malignancy or Lymphoma Relapsed or refractory disease after at least 1 prior systemic treatment for the primary malignancy and not a candidate for other curative treatment. Adequate hematologic status Adeq...

Countries:United States
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