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REGN1400

Phase 1

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

REGN1400 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Nov 2012

REGN1400 target and mechanism

Molecular targetErbB3
Target classProtein
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment56

FDA Designations

No designations recorded

REGN1400 clinical trials

REGN1400 · 1 trial · 1 indication

Phase 1 1
NCT01727869Study of REGN1400 Alone and in Combination With Erlotinib or Cetuximab in Patients With Certain Types of CancerCancer
COMPLETED56 Analytics
PHASE1COMPLETED
Study of REGN1400 Alone and in Combination With Erlotinib or Cetuximab in Patients With Certain Types of Cancer
CancerUnlock trial analytics

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 to 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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Competitive Landscape -Cancer 7 trials

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Frequently asked questions about REGN1400

What is REGN1400?

REGN1400 is an investigational small molecule being developed by Regeneron Pharmaceuticals for the treatment of cancer. It is an oncology candidate that has been studied in a Phase 1 clinical trial, both as a single agent and in combination with other cancer therapies. It is not an approved medicine.

What does REGN1400 target?

REGN1400 targets ErbB3, a protein receptor. By binding to ErbB3, the small molecule is designed to interfere with signaling through this receptor, which is part of the ErbB family of growth factor receptors implicated in cancer cell growth and survival.

Who makes REGN1400?

REGN1400 is developed by Regeneron Pharmaceuticals, Inc., which trades on the Nasdaq under the ticker REGN. Regeneron is the sponsor of the clinical program studying this small molecule oncology candidate.

What phase is REGN1400 in?

REGN1400 is in Phase 1 development. It is an investigational drug and has not been approved by the FDA. The Phase 1 program has been completed, with one registered trial that enrolled 56 patients.

What clinical trials is REGN1400 in?

REGN1400 has been studied in one Phase 1 trial, NCT01727869, titled a study of REGN1400 alone and in combination with erlotinib or cetuximab in patients with certain types of cancer. That trial is completed, enrolled 56 patients in the United States, and included adults 18 years and older.

What is REGN1400 used for in cancer?

REGN1400 was studied in patients with certain types of cancer. The Phase 1 trial evaluated the drug both as a single agent and in combination with erlotinib or cetuximab. It remains an investigational therapy and is not approved for any cancer indication.