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OKI-179

Phase 2

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

OKI-179 development status

Highest phase Phase 2
Registered trials 1 across 1 sponsor since Apr 2001

OKI-179 target and mechanism

Molecular targetHDAC
Target classClass I Hdac Inhibitor
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDBiomarker
Total Trials2
Total Enrollment70

FDA Designations

No designations recorded

OKI-179 clinical trials

OKI-179 · 2 trials · 4 indications

Phase 1/2 1Phase 1 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.
OKI-179DRUGOKI-179 single agent
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Competitive Landscape -Genetic Mutations 12 trials (matched to "RAS Mutation")

Frequently asked questions about OKI-179

What is OKI-179?

OKI-179 is an investigational small molecule developed by OnKure Therapeutics, Inc. (ticker OKUR) for advanced solid tumors, including cancers with RAS pathway mutations. It is a Class I HDAC inhibitor and has been studied in Phase 1 and Phase 1b/2 clinical trials, both of which are now completed.

What does OKI-179 target?

OKI-179 targets HDAC, specifically Class I histone deacetylases. As a Class I HDAC inhibitor, it is designed to interfere with HDAC enzyme activity in tumor cells. It has been evaluated in advanced solid tumors and RAS-mutated cancers, including in combination with the MEK inhibitor binimetinib.

Who makes OKI-179?

OKI-179 is developed by OnKure Therapeutics, Inc., which trades under the ticker OKUR. The company has sponsored the clinical studies of OKI-179, including the Phase 1 study in solid tumors and the Phase 1b/2 NAUTILUS study of OKI-179 plus binimetinib.

What phase is OKI-179 in?

OKI-179 is in Phase 1 development. It has been tested in a Phase 1 study and a Phase 1b/2 study, both of which are completed. OKI-179 is investigational and has not been approved by the FDA for any indication.

What clinical trials is OKI-179 in?

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