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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, including tumors with RAS mutations and NRAS-mutated melanoma. It is being developed by OnKure Therapeutics, Inc. (NASDAQ: OKUR) and is currently in clinical development, though it 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. By inhibiting this pathway, it aims to treat cancers driven by RAS mutations, including NRAS-mutated melanoma. The drug is being studied in combination with binimetinib in certain trials.

Who makes OKI-179?

OKI-179 is being developed by OnKure Therapeutics, Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol OKUR. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with advanced solid tumors.

What phase is OKI-179 in?

OKI-179 is in Phase 1 clinical development. Two trials have been completed: a Phase 1 study in advanced solid tumors and a Phase 1/2 study in RAS pathway tumors and NRAS-mutated melanoma. The drug is investigational and has not received FDA approval.

What clinical trials is OKI-179 in?

OKI-179 has been studied in two completed clinical trials. NCT03931681 was a Phase 1 study in patients with advanced solid tumors, enrolling 34 participants. NCT05340621, called NAUTILUS, was a Phase 1/2 study of OKI-179 plus binimetinib in patients with RAS pathway tumors and NRAS-mutated melanoma, enrolling 36 participants.

Is OKI-179 the same as other drugs?

OKI-179 is a distinct investigational drug and is not known to have alternative names. It is being studied alone and in combination with binimetinib, a MEK inhibitor, but it is not the same compound as binimetinib or any other approved therapy.