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OKI-179 + Binimetinib for Melanoma

Phase 1 & 2
Recruiting
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 1b: Solid tumor refractory to standard treatment, for which no standard therapy is available, or if the patient refuses standard therapy
Phase 1b: Tumor has an activating mutation in the RAS pathway confirmed by any local or central laboratory, including but not limited to RAS, BRAF, NF1, and GNAQ/11
Timeline
Screening 3 weeks
Treatment Varies
Follow Up phase 1b study duration (approximately 1.5 years)
Awards & highlights
No Placebo-Only Group

Study 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...
My solid tumor hasn't responded to standard treatments, or there are none available, or I refuse them.
Select...
My tumor has a mutation in the RAS pathway.
Select...
My melanoma is metastatic with a confirmed NRAS mutation.
Select...
I have previously been treated with or am ineligible for PD-1/PD-L1 therapy.
Select...
I have at least one tumor that can be measured.
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My liver enzymes are within the required limits.
Select...
I may have been treated with a MEK inhibitor, pending approval.
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I am fully active or restricted in physically strenuous activity but can do light work.
Select...
My blood tests for organ and bone marrow function are normal.
Select...
I can take pills by mouth without difficulty.
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All my previous treatment side effects are mild, except for hair loss and certain hormone issues treated with medication.
Select...
My bilirubin levels are normal or slightly higher due to Gilbert's syndrome.

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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

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

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available spots left for people in this clinical trial?

"That's right. The listing on clinicaltrials.gov makes it clear that the research team is currently seeking participants. This trial was originally posted on May 11th, 2022 and updated September 22nd of the same year. They are looking for 73 individuals total, at 7 different locations."

Answered by AI

In how many different medical centers is this research project being run today?

"There are 7 clinical trial sites for this study. The University of Texas MD Anderson Cancer Center in Houston, CTCA Phoenix, part of City of Hope in Phoenix, and Massachusetts General Hospital in Boston are all conducting research for this project, as well as 4 other locations."

Answered by AI

How many people will be involved in this trial at most?

"The sponsor, OnKure Inc., needs to recruit 73 eligible patients from specific cancer treatment centres in America - such as University of Texas MD Anderson Cancer Center and CTCA Phoenix."

Answered by AI
~39 spots leftby Mar 2026