← Back to Search

Other

OKI-179 + Binimetinib for Melanoma

Phase 1 & 2
Waitlist Available
Led By Ryan Sullivan, MD
Research Sponsored by OnKure, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Phase 2: Prior ICI treatment with a programmed cell death 1 (PD-1) or programmed death ligand 1 (PD-L1) checkpoint inhibitor, or ineligible for this type of therapy
Phase 1b: Solid tumor refractory to standard treatment, for which no standard therapy is available, or if the patient refuses standard therapy
Must not have
Patients who have neuromuscular disorders that are associated with elevated creatine phosphokinase (CPK; eg, inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis, spinal muscular atrophy) or elevated baseline CPK levels (≥ Grade 2)
Known positive serology for HIV and AIDS-related illness with CD4 count < 350/mL and/or known active hepatitis B or hepatitis C. Testing prior to C1D1 is not required
Timeline
Screening 3 weeks
Treatment Varies
Follow Up phase 1b study duration (approximately 1.5 years)
Awards & highlights

Summary

This trial will test a new combination therapy for people with RAS-mutated melanoma.

Who is the study for?
This trial is for adults with advanced solid tumors in the RAS pathway or NRAS-mutated melanoma. They must have normal organ and marrow function, be able to swallow oral meds, and not be pregnant or nursing. Exclusions include hypersensitivity to MEK inhibitors, certain eye conditions, uncontrolled heart disease, severe infections like HIV/AIDS, recent major surgery or chemotherapy.Check my eligibility
What is being tested?
The NAUTILUS study tests OKI-179 combined with binimetinib on patients with specific mutations in their tumors. Phase 1b focuses on various solid tumors while Phase 2 targets NRAS-mutated melanoma specifically. It's an open-label study where everyone knows what treatment they're getting.See study design
What are the potential side effects?
Potential side effects may include typical reactions to cancer medications such as fatigue, digestive issues (nausea/vomiting), skin rash from binimetinib use, liver enzyme changes requiring monitoring of blood tests regularly and possible visual disturbances due to drug sensitivity.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have previously been treated with or am ineligible for PD-1/PD-L1 therapy.
Select...
My solid tumor hasn't responded to standard treatments, or there are none available, or I refuse them.
Select...
My melanoma is metastatic with a confirmed NRAS mutation.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
I can take pills by mouth without difficulty.
Select...
My tumor has a mutation in the RAS pathway.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have a muscle disorder that causes high CPK levels.
Select...
I have HIV/AIDS with a CD4 count below 350, or active hepatitis B or C.
Select...
My high blood pressure is not controlled by medication.
Select...
I am not pregnant or nursing.
Select...
I am currently taking medication that strongly affects liver enzyme levels.
Select...
I do not have conditions that would make taking pills difficult.
Select...
I have not used specific cancer treatments like HDAC inhibitors or MEK inhibitors.
Select...
I have not had major surgery in the last 4 weeks.
Select...
I am currently taking medication that strongly affects drug transport in my body.
Select...
I have a history of long QT syndrome.
Select...
I have not had chemotherapy or radiation in the last 2 weeks.
Select...
I do not have serious heart problems.
Select...
I have a history of specific eye conditions or risks for them, like uncontrolled glaucoma.
Select...
I am on medication that affects my heart's rhythm.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~phase 1b study duration (approximately 1.5 years)
This trial's timeline: 3 weeks for screening, Varies for treatment, and phase 1b study duration (approximately 1.5 years) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Phase 1b: Change in Eastern Cooperative Oncology Group (ECOG) performance status
Phase 1b: Change in clinical laboratory abnormalities
Phase 1b: Incidence and severity of adverse events (AEs)
+2 more
Secondary outcome measures
Phase 1b: Area Under the Plasma Concentration vs. Time Curve (AUC) of OKI-179 and OKI-006
Phase 1b: Clinical Benefit Rate (CBR)
Phase 1b: Duration of Response (DOR)
+8 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: OKI-179 + binimetinibExperimental Treatment1 Intervention

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
MEK inhibitors, such as binimetinib, target the MEK enzyme in the MAPK/ERK pathway, which is frequently overactive in melanoma due to mutations in proteins like BRAF or NRAS. By inhibiting MEK, these drugs can decrease cell proliferation and promote apoptosis in melanoma cells. This targeted approach is important for melanoma patients as it offers a more effective and personalized treatment option, potentially improving outcomes and minimizing side effects compared to traditional chemotherapy.

Find a Location

Who is running the clinical trial?

OnKure, Inc.Lead Sponsor
2 Previous Clinical Trials
184 Total Patients Enrolled
Ryan Sullivan, MDPrincipal InvestigatorMassachusetts General Hospital
2 Previous Clinical Trials
256 Total Patients Enrolled
2 Trials studying Melanoma
256 Patients Enrolled for Melanoma

Media Library

Binimetinib (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05340621 — Phase 1 & 2
~15 spots leftby Mar 2026
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top