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MEK162 and mFOLFIRI

Phase 1

Advanced KRAS Positive Metastatic Colorectal Cancer | Small molecule | Oncology |Pfizer, Inc.|Last Updated: May 12, 2026

Target and mechanism

Molecular targetMAP2K2, MAP2K1
Target classInhibitor
ModalitySmall molecule

Also known as Binimetinib, binimetinib

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment25

FDA Designations

No designations recorded

Clinical trial landscape

MEK162 and mFOLFIRI · 1 trial · 1 indication

Phase 1 1
NCT02613650A Trial of mFOLFIRI With MEK162 in Patients With Advanced RAS (HRAS, NRAS, or KRAS) Positive Metastatic Colorectal CancersAdvanced KRAS Positive Metastatic Colorectal Cancer
COMPLETED25 Analytics
PHASE1COMPLETED
A Trial of mFOLFIRI With MEK162 in Patients With Advanced RAS (HRAS, NRAS, or KRAS) Positive Metastatic Colorectal Cancers
Advanced KRAS Positive Metastatic Colorectal CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Incidence of dose limiting toxicities (DLTs) of combination MEK162 and mFOLFIRI
Patient safety will be evaluated throughout the treatment period (treatment with MEK162 and mFOLFIRI which is expected to last 6-10 months for each patient)

Secondary Endpoints

Response Rate
2 months
Clinical benefit rate
4 months
Additional Safety
9 months
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
MEK162 and mFOLFIRI, all patientsEXPERIMENTAL -

Interventions

NameTypeDescription
MEK162 and mFOLFIRIDRUGMEK162 in combination with mFOLFIRI in a 14 day cycle MEK162 will be given single agent 6 day lead in and then will be given in combination with mFOLFIRI mFOLFIRI Administered Day 1 of each cycle Irinotecan 180mg/m2 iv over 90 minutes on day 1 5-fluoruracil 1200mg/m2 continuous infusion for 48 hours (2400mg/m2 in 48 hours) Followed by MEK162 - Taken twice daily orally on Days 1-12 of each cycle Level -1: mFOLFIRI at 80% + MEK162 30 mg twice daily 1 week on and 1 week off Level 1: mFOLFIRI + MEK162 30 mg twice daily Level 2: mFOLFIRI + MEK162 45 mg twice daily
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Age \> 18 years old * Patients with histologically confirmed RAS (HRAS, NRAS, or KRAS) positive metastatic colorectal cancer. * Patients must have progressed during or after first-line treatment for metastatic disease with oxaliplatin and fluoropyrimidines based chemotherapy (...

Countries:United States
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Recent Changes (Last 90 Days)

MEDIUMJun 12, 2026NCT02613650TRIAL_REMOVED: changed
MEDIUMJun 12, 2026NCT02613650TRIAL_REMOVED: changed
MEDIUMJun 12, 2026NCT02613650TRIAL_REMOVED: changed

Frequently asked questions about MEK162 and mFOLFIRI

What is Binimetinib used for?

Binimetinib is an investigational small molecule kinase inhibitor being studied in oncology. It is being evaluated for epithelial ovarian cancer, advanced solid tumors, metastatic colorectal cancer, advanced KRAS positive metastatic colorectal cancer, BRAF or NRAS mutant metastatic melanoma, and melanoma stage III. It is currently in Phase 2 clinical development.

What does Binimetinib target?

Binimetinib is a kinase inhibitor, belonging to the -tinib class of drugs. It targets MEK, a kinase in the RAS/RAF/MEK/ERK pathway. By inhibiting MEK, it is designed to block signaling that drives tumor growth in cancers with RAS or BRAF mutations.

Who makes Binimetinib?

Binimetinib is being developed by Pfizer, Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol PFE. The drug is currently in Phase 2 clinical trials for multiple oncology indications.

What phase is Binimetinib in?

Binimetinib is currently in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA. It is being studied across multiple oncology indications, including advanced solid tumors and metastatic colorectal cancer.

What clinical trials is Binimetinib in?

Binimetinib has been studied in several clinical trials. NCT01352273 was a Phase 1 trial in advanced solid tumors with RAS or BRAFV600E mutations. NCT01649336 was a Phase 1 trial in ovarian, fallopian tube, or peritoneal cancer. NCT01763164 was a Phase 3 trial in NRAS-mutant melanoma. NCT03271047 is a Phase 2 trial in MSS, RAS-mutant colorectal cancer.

Is Binimetinib the same as MEK162?

Yes, Binimetinib is also known as MEK162. Clinical trials such as NCT01352273 and NCT01649336 refer to the drug as MEK162. This alternative name is used in research settings and historical trial documentation.