CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 36 enrolled
Drug / intervention
OKI-179 + binimetinibdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

In the news

8 articles

Matched to this trial by ClinicalIndexfrom reputable biotech & medical press.

Search/NCT05340621
NCT05340621Phase 2Completed
CompareCT.gov

NAUTILUS: a Phase 1b/2 Study of OKI-179 Plus Binimetinib in Patients with Advanced Solid Tumors and Activating Mutations in the RAS Pathway (Phase 1b) and in Patients with Advanced NRAS-Mutated Melanoma (Phase 2)

OnKure, Inc.·interventional·Posted Apr 22, 2022·Updated Mar 7, 2025

In Brief

A Phase 2 clinical trial evaluating OKI-179 + binimetinib for RAS Mutation and 2 related conditions. Completed, enrolled 36 participants across 12 sites.

Detailed Summary

The NAUTILUS study is a Phase 1b/2, multi-center, open-label study in which patients with activating mutations in the RAS pathway (Phase 1b) and patients with NRAS-mutated Melanoma (Phase 2) will be treated with a combination of oral OKI-179 combined with the MEK inhibitor binimetinib.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRAS Mutation, NRAS Gene Mutation, Melanoma
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2023202420252026
First PostedApr 22, 2022
Enrollment StartMay 11, 2022
Primary CompletionJan 29, 2025
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 4.2 years ago

Interventions

OKI-179 + binimetinibdrug

Phase 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.