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REGN1400

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment56

FDA Designations

No designations recorded

Clinical trial landscape

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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Frequently asked questions about REGN1400

What is REGN1400 used for?

REGN1400 is an investigational small molecule being developed by Regeneron Pharmaceuticals for the treatment of cancer. It is currently in Phase 1 clinical development, meaning it has not yet been approved by regulatory authorities and is still being studied for safety and efficacy in patients.

Who makes REGN1400?

REGN1400 is being developed by Regeneron Pharmaceuticals, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker symbol REGN. The company is conducting clinical trials to evaluate the drug's safety and potential efficacy in treating cancer.

What phase is REGN1400 in?

REGN1400 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by the FDA or other regulatory agencies. The drug is being studied in a completed Phase 1 trial to assess its safety, tolerability, and preliminary efficacy in patients with cancer.

What clinical trials is REGN1400 in?

REGN1400 has been studied in one clinical trial, identified by the identifier NCT01727869. This was a Phase 1 study that evaluated REGN1400 alone and in combination with erlotinib or cetuximab in patients with certain types of cancer. The trial, which enrolled 56 participants, has been completed.

Is REGN1400 the same as erlotinib or cetuximab?

No, REGN1400 is a distinct investigational drug. In the clinical trial NCT01727869, REGN1400 was studied both alone and in combination with erlotinib or cetuximab, which are separate cancer medications. The trial was designed to evaluate the safety and efficacy of REGN1400 when used by itself or alongside these other treatments.