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OKI-179 + binimetinib

Phase 2

RAS Mutation | Small molecule | Oncology |OnKure Therapeutics, Inc.|Last Updated: Mar 6, 2025

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment36

FDA Designations

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Clinical trial landscape

OKI-179 + binimetinib · 1 trial · 3 indications

Phase 1/2 1
NCT05340621NAUTILUS: OKI-179 Plus Binimetinib in Patients with Advanced Solid Tumors in the RAS Pathway (Phase 1b) and NRAS-mutated Melanoma (Phase 2)RAS Mutation
COMPLETED36 Analytics
PHASE1/PHASE2COMPLETED
NAUTILUS: OKI-179 Plus Binimetinib in Patients with Advanced Solid Tumors in the RAS Pathway (Phase 1b) and NRAS-mutated Melanoma (Phase 2)
RAS MutationUnlock trial analytics

Study Design & Arms

Interventions

NameTypeDescription
OKI-179 + binimetinibDRUGPhase 1b: With a 3+3 dose escalation design, enrollment in Phase 1b will proceed until the MTD has been defined or the highest dose level has been reached. OKI-179 will be administered on a 4-days-on/3-days-off schedule, while binimetinib will be administered BID continuously. Phase 2: Patients will be treated with the RP2D.
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Competitive Landscape -Genetic Mutations 6 trials (matched to "RAS Mutation")

Frequently asked questions about OKI-179 + binimetinib

What is OKI-179 used for?

OKI-179 is an investigational small molecule being studied for the treatment of advanced solid tumors and cancers with RAS pathway mutations, including NRAS-mutated melanoma. It is currently in clinical development and has not been approved by the FDA.

What does OKI-179 target?

OKI-179 is a small molecule that targets the RAS pathway, which is involved in cell growth and division. It is being studied in patients with RAS mutations, including NRAS gene mutations, to potentially treat advanced solid tumors and melanoma.

Who makes OKI-179?

OKI-179 is being developed by OnKure Therapeutics, Inc., a biopharmaceutical company. OnKure is publicly traded on the NASDAQ under the ticker symbol OKUR.

What phase is OKI-179 in?

OKI-179 is in Phase 1 clinical development. It has completed a Phase 1 trial and a Phase 1/2 trial, but it is still investigational and has not been approved by the FDA.

What clinical trials is OKI-179 in?

OKI-179 has been studied in two clinical trials. The first, NCT03931681, was a Phase 1 study in patients with advanced solid tumors. The second, NCT05340621, was a Phase 1/2 study called NAUTILUS, which evaluated OKI-179 plus binimetinib in patients with advanced solid tumors in the RAS pathway and NRAS-mutated melanoma.

Is OKI-179 the same as another drug?

OKI-179 is also known by its code name OKI-179. It is sometimes referred to as OKI-179 in clinical trial records. No other alternative names have been reported.