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nesvacumab

Phase 1

Solid Tumors | Monoclonal antibody | Oncology |Regeneron Pharmaceuticals, Inc.|Trials Updated: Jun 16, 2015

nesvacumab target and mechanism

Molecular targetANGPT2
Target classInhibitor
ModalityMonoclonal antibody

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDDMC
Total Trials2
Total Enrollment101

FDA Designations

No designations recorded

nesvacumab clinical trials

nesvacumab · 2 trials · 1 indication

Phase 1 2
NCT01688960Nesvacumab (REGN910/ SAR307746) and Aflibercept ("Ziv-aflibercept" in the U.S.) in Patients With Advanced Solid MalignanciesSolid Tumors
COMPLETED48 Analytics
NCT01271972Study of Nesvacumab (REGN910/ SAR307746)Solid Tumors
COMPLETED53 Analytics
PHASE1COMPLETED
Nesvacumab (REGN910/ SAR307746) and Aflibercept ("Ziv-aflibercept" in the U.S.) in Patients With Advanced Solid Malignancies
Solid TumorsUnlock trial analytics
PHASE1COMPLETED
Study of Nesvacumab (REGN910/ SAR307746)
Solid TumorsUnlock trial analytics

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 to 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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Competitive Landscape -Other Solid Tumors 10 trials (matched to "Solid Tumors")

Frequently asked questions about nesvacumab

What is nesvacumab?

Nesvacumab is an investigational monoclonal antibody developed by Regeneron Pharmaceuticals, Inc. (ticker: REGN) for the treatment of solid tumors. It is an ANGPT2 inhibitor that has been studied in Phase 1 clinical trials in patients with advanced solid malignancies.

What is nesvacumab used for?

Nesvacumab has been studied for the treatment of solid tumors in adults. Both of its Phase 1 trials enrolled patients with advanced solid malignancies, and one trial evaluated nesvacumab in combination with aflibercept, known as Ziv-aflibercept in the United States.

What does nesvacumab target?

Nesvacumab targets ANGPT2, also known as angiopoietin-2. It is an ANGPT2 inhibitor monoclonal antibody. By binding ANGPT2, nesvacumab is designed to interfere with angiopoietin-2 signaling, a pathway involved in tumor angiogenesis and vascular biology.

Who is developing nesvacumab?

Nesvacumab is developed by Regeneron Pharmaceuticals, Inc., which trades under the ticker REGN. The drug is also identified by the code names REGN910 and SAR307746, reflecting its development history.

What phase is nesvacumab in?

Nesvacumab is in Phase 1 clinical development. It is an investigational agent and has not been approved by the FDA. Both of its Phase 1 trials in solid tumors are listed as completed, and no trials are currently active.

What clinical trials is nesvacumab in?

Nesvacumab has been evaluated in two completed Phase 1 trials. NCT01688960 studied nesvacumab with aflibercept in advanced solid malignancies and enrolled 48 patients. NCT01271972 studied nesvacumab alone in solid tumors and enrolled 53 patients. Both trials were conducted in the United States and Canada.

Is nesvacumab the same as REGN910 or SAR307746?

Yes. Nesvacumab is also known as REGN910 and SAR307746. REGN910 is Regeneron's internal code for the antibody, while SAR307746 reflects the compound's designation under a collaboration with Sanofi. All three names refer to the same ANGPT2 inhibitor monoclonal antibody.