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nesvacumab

Phase 1

Solid Tumors | Small molecule | Oncology |Regeneron Pharmaceuticals, Inc.|Last Updated: Jun 16, 2015

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDDMC
Total Trials2
Total Enrollment101

FDA Designations

No designations recorded

Clinical trial landscape

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 9 trials (matched to "Solid Tumors")

Frequently asked questions about nesvacumab

What is nesvacumab used for?

Nesvacumab is an investigational drug being studied for the treatment of solid tumors. It is a small molecule developed by Regeneron Pharmaceuticals, Inc. (REGN). As of the available data, nesvacumab is in Phase 1 clinical development and has not been approved by the FDA.

Who makes nesvacumab?

Nesvacumab is being developed by Regeneron Pharmaceuticals, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker symbol REGN. The drug is in Phase 1 clinical development for the treatment of solid tumors.

What phase is nesvacumab in?

Nesvacumab is in Phase 1 clinical development. It is an investigational drug for solid tumors and has not been approved by regulatory authorities. Two Phase 1 trials have been completed, with a total of 101 participants enrolled.

What clinical trials is nesvacumab in?

Nesvacumab has been studied in two completed Phase 1 clinical trials. The first, NCT01271972, enrolled 53 participants with solid tumors. The second, NCT01688960, enrolled 48 participants with advanced solid malignancies and evaluated nesvacumab in combination with aflibercept. 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. These alternative names appear in the titles of its clinical trials, such as NCT01271972 and NCT01688960, which refer to the drug by these identifiers.