NCT05340621

NAUTILUS: OKI-179 Plus Binimetinib in Patients with Advanced Solid Tumors in the RAS Pathway (Phase 1b) and NRAS-mutated Melanoma (Phase 2)

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)

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: OnKure, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• RAS Mutation
• NRAS Gene Mutation
• Melanoma

Interventions

Type	Name	Description
DRUG	OKI-179 + binimetinib	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.

Timeline

• Start date: 2022-05-11
• Primary completion: 2025-01-29
• Completion: 2025-01-29
• First posted: 2022-04-22
• Last updated: 2025-03-07

Locations

12 sites across 1 country: United States

Regulatory

• FDA-regulated drug study