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REGN1400

Phase 1

Cancer | Small molecule | Oncology |Regeneron Pharmaceuticals, Inc.|Last Updated: Apr 6, 2015

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
CONTROLLEDBiomarker
Total Trials1
Total Enrollment56
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01727869Study of REGN1400 Alone and in Combination With Erlotinib or Cetuximab in Patients With Certain Types of CancerPHASE1 COMPLETED 56Oct 1, 2012Jan 1, 2015Apr 6, 20156 United States
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Study Endpoints
Primary Endpoints
The primary objective of the study is to characterize the safety profile of REGN1400 alone and in combination with erlotinib or cetuximab
Day 1 - Day 28

Safety will be assessed through analysis of laboratory data, physical examination findings and vital signs according to the schedule of assessments, in addition to the spontaneous reporting of adverse events according to CTCAE version 4.

Secondary Endpoints
Recommended Phase 2 Dose (RP2D)
Day 1 to Day 28
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Cohort 1EXPERIMENTALDosing regimen 1: REGN1400 or REGN1400 and erlotinib or REGN1400 and cetuximab
Cohort 2EXPERIMENTALDosing regimen 2: REGN1400 or REGN1400 and erlotinib or REGN1400 and cetuximab
Cohort 3EXPERIMENTALDosing regimen 3: REGN1400 or REGN1400 and erlotinib or REGN1400 and cetuximab
Interventions
NameTypeDescription
REGN1400DRUG -
ErlotinibDRUG -
CetuximabDRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites6

Inclusion Criteria include, but are not limited to, the following: 1. Confirmed diagnosis of certain unresectable or metastatic cancers 2. Adequate Eastern Cooperative Oncology Group (ECOG) performance status 3. Adequate hepatic, renal and bone marrow function 4. Resolution of toxicity from prior t...

Countries:United States
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