Your session is about to expire
← 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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up phase 1b study duration (approximately 1.5 years)
Awards & highlights
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ phase 1b study duration (approximately 1.5 years)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~phase 1b study duration (approximately 1.5 years)
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 moreSecondary 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 moreTrial 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a muscle disorder that causes high CPK levels.I have previously been treated with or am ineligible for PD-1/PD-L1 therapy.My high blood pressure is not controlled by medication.My solid tumor hasn't responded to standard treatments, or there are none available, or I refuse them.I am not pregnant or nursing.I am currently taking medication that strongly affects liver enzyme levels.My bilirubin levels are normal or slightly higher due to Gilbert's syndrome.I haven't had a heart attack or other major heart issues in the last 6 months.My melanoma is metastatic with a confirmed NRAS mutation.I do not have conditions that would make taking pills difficult.I have not used specific cancer treatments like HDAC inhibitors or MEK inhibitors.I have not had major surgery in the last 4 weeks.I have brain metastases but am stable and not on steroids, or they are small and not causing symptoms.You have a serious medical or mental condition that the doctor thinks would make it unsuitable for you to join the study.I have not had serious heart issues like heart failure or irregular heartbeat in the last 6 months.I am currently taking medication that strongly affects drug transport in my body.Your white blood cell count needs to be higher than 1.5 billion per liter.All my previous treatment side effects are mild, except for hair loss and certain hormone issues treated with medication.My liver enzymes are within the required limits.I have no other active cancers or had any cancer other than minor ones in the last 2 years.I have HIV/AIDS with a CD4 count below 350, or active hepatitis B or C.I have at least one tumor that can be measured.I have not had a major clot or stroke in the last 3 months, or if I have, I've been on blood thinners for 4 weeks.I have a history of long QT syndrome.I am fully active or restricted in physically strenuous activity but can do light work.I have not had chemotherapy or radiation in the last 2 weeks.I do not have serious heart problems.You are expected to live for at least 3 more months.You are allergic to binimetinib or similar medications for MEK inhibitors.I have a history of specific eye conditions or risks for them, like uncontrolled glaucoma.I may have been treated with a MEK inhibitor, pending approval.My blood tests for organ and bone marrow function are normal.Your kidney function, as measured by a blood test for creatinine, is within a certain normal range.I am on medication that affects my heart's rhythm.Your heart's pumping ability (LVEF) is at least 50%.I can take pills by mouth without difficulty.Your platelet count should be at least 100,000 per microliter.Your hemoglobin level is at least 9.0 grams per deciliter.Your ECG shows a specific heart rhythm that could be a concern for the study.I haven't taken experimental drugs recently or still have side effects from them.I have not had major eye problems or surgeries, except for LASIK or due to uveal melanoma.My tumor has a mutation in the RAS pathway.
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
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger