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MEK162+ RAF265

Phase 1

Advanced Solid Tumors | Small molecule | Oncology |Pfizer, Inc.|Last Updated: Sep 30, 2020

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

UNCONTROLLED
Total Trials1
Total Enrollment69

FDA Designations

No designations recorded

Clinical trial landscape

MEK162+ RAF265 · 1 trial · 1 indication

Phase 1 1
NCT01352273MEK162 and RAF265 in Adult Patients With Advanced Solid Tumors Harboring RAS or BRAFV600E MutationsAdvanced Solid Tumors
COMPLETED69 Analytics
PHASE1COMPLETED
MEK162 and RAF265 in Adult Patients With Advanced Solid Tumors Harboring RAS or BRAFV600E Mutations
Advanced Solid TumorsUnlock trial analytics

Study Endpoints

Primary Endpoints

Incidence of Dose Limiting Toxicities
during the first 28 days of treatment with RAF265 and MEK162

Secondary Endpoints

Number of participants with adverse events and serious adverse events
18 months
assess preliminary anti-tumor activity of the combination
every 8 weeks of treatment
Tumor skin and blood samples will be collected before and during treatment with RAF265 and MEK162 to assess the combination's effects on the RAF/MEK/MAPK pathway with the clinical outcomes
18 months
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
MEK162 + RAF265EXPERIMENTAL -

Interventions

NameTypeDescription
MEK162 + RAF265DRUG -
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites8

Inclusion Criteria: Patients with histologically or cytologically confirmed and non-resectable advanced solid tumors for which no further effective standard therapy exists. * The patients' tumors must contain documented activating somatic BRAFV600E\* , NRAS or KRAS mutations (except for pancreatic...

Countries:United StatesCanadaNorwaySpainSwitzerland
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Competitive Landscape -Other Solid Tumors 9 trials (matched to "Advanced Solid Tumors")

Frequently asked questions about MEK162+ RAF265

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.