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nesvacumab

Phase 1

Solid Tumors | Small molecule | Oncology |Regeneron Pharmaceuticals, Inc.|Last Updated: Jun 16, 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
CONTROLLEDDMCBiomarker
Total Trials2
Total Enrollment101
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01688960Nesvacumab (REGN910/ SAR307746) and Aflibercept ("Ziv-aflibercept" in the U.S.) in Patients With Advanced Solid MalignanciesPHASE1 COMPLETED 48Oct 1, 2012Nov 1, 2014Mar 17, 20156 United States, Canada
NCT01271972Study of Nesvacumab (REGN910/ SAR307746)PHASE1 COMPLETED 53Jan 1, 2011May 1, 2015Jun 16, 20153 United States, Canada
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Study Endpoints
Primary Endpoints
Maximum Tolerable Dose (MTD) or Recommended Phase 2 Dose (RP2D)
Day 1 to Day 28

Determine the maximum tolerable dose or recommended phase 2 dose of nesvacumab (REGN910/ SAR307746) administered in combination with aflibercept (ziv-aflibercept) in patients with advanced solid malignancies

Determine the maximum tolerable dose or recommended phase 2 dose of nesvacumab (REGN910/ SAR307746) in patients with advanced solid malignancies
28 days
Secondary Endpoints
Pharmacokinetics (PK)
Day 1 to Day 170
Immunogenicity
Day 1 to Day 170
Antitumor activity
Day 1 to Day 170
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Cohort 1EXPERIMENTAL -
Cohort 2EXPERIMENTAL -
Cohort 3aEXPERIMENTAL -
Cohort 3bEXPERIMENTAL -
Cohort 4EXPERIMENTAL -
Cohort 3EXPERIMENTALDose 3
Cohort 5EXPERIMENTALDose 5
Expansion Cohort 1EXPERIMENTALDose 4
Expansion Cohort 2EXPERIMENTALDose 5
Interventions
NameTypeDescription
nesvacumab (REGN910/ SAR307746)DRUGDose level 1
aflibercept (ziv-aflibercept)DRUGDose level 1
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites6

Inclusion Criteria: Inclusion criteria include, but are not limited to, the following: 1. Confirmed diagnosis of solid tumor malignancy 2. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 3. Adequate hepatic, renal and bone marrow function 4. Resolution of toxicity from prior th...

Countries:United StatesCanada
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