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NCT05340621 · ClinicalTrials.gov registry record · Phase 1
NAUTILUS: OKI-179 Plus Binimetinib in Patients with Advanced Solid Tumors in the RAS Pathway (Phase 1b) and NRAS-mutated Melanoma (Phase 2)
A Phase 1 study, sponsored by OnKure.
- Completed
- Registry status
- Phase 1
- Development phase
- 36
- Enrollment target
NCT05340621: Completed Phase 1 study, sponsored by OnKure.
NCT05340621 is a Phase 1 study that has completed, run by OnKure. The registered enrollment target is 36 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (40% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05340621, a Phase 1 study, has completed, sponsored by OnKure.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 36 participants
- Enrollment target
Study 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.
Primary Outcome
Incidence and severity of DLTs will be measured in the DLT-evaluable population during Cycle 1.
Interventions
- DRUG OKI-179 + binimetinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2022-05-11 |
| Est. Completion | 2025-01-29 |
| Phase | Phase 1 |
What the finished NCT05340621 record still lists
NCT05340621 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (40% lower).
The record links to 0 conditions, and to 1 intervention - of which OKI-179 + binimetinib is the first listed.
NCT05340621 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05340621 about?
NCT05340621 is a clinical study titled "NAUTILUS: OKI-179 Plus Binimetinib in Patients with Advanced Solid Tumors in the RAS Pathway (Phase 1b) and NRAS-mutated Melanoma (Phase 2)". 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.
What is the current status of trial NCT05340621?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2022-05-11. Estimated completion is 2025-01-29.
What interventions are being tested in trial NCT05340621?
The interventions under investigation include: OKI-179 + binimetinib (DRUG).
Who is sponsoring clinical trial NCT05340621?
This trial is sponsored by OnKure, which has 3 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05340621's enrollment target sits among peer trials
36 1210th of 2000 higher than 743 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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