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REGN421

Phase 1

Advanced Solid Malignancies | Small molecule | Other |Regeneron Pharmaceuticals, Inc.|Last Updated: Mar 26, 2014

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 Enrollment83
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00871559A Multiple-Ascending-Dose Study of the Safety and Tolerability of REGN421(SAR153192) in Patients With Advanced Solid MalignanciesPHASE1 COMPLETED 83Jun 1, 2009Feb 1, 2014Mar 26, 20148 United States
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Study Endpoints
Primary Endpoints
Safety and tolerability
18 months
Secondary Endpoints
Preliminary evidence of antitumor activity
18 months
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Q2WEXPERIMENTALREGN421 (SAR153192) taken once every two weeks (Q2W)
Interventions
NameTypeDescription
REGN421(SAR153192)DRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites8

Inclusion Criteria: 1. Male or female 18 years of age or older 2. Histologically diagnosis of advanced solid malignancy, with no standard therapeutic options of proven benefit. 3. Patients with measurable or non-measurable disease 4. At least 6 weeks must have elapsed since the last dose of bevaciz...

Countries:United States
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