OKI-179 + Binimetinib for Melanoma

Recruiting at 13 trial locations

Overseen By Onkure, Inc.

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: OnKure, Inc.

Must not be taking: Corticosteroids, Valproic acid

Disqualifiers: Pregnancy, Brain metastasis, Cardiovascular, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

36 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests a combination of two oral medications, OKI-179 and binimetinib, in patients with specific genetic mutations in their cancer. It targets those with RAS pathway mutations and NRAS-mutated Melanoma. The treatment works by blocking signals that help cancer cells grow and divide. Binimetinib is a selective MEK1/2 inhibitor approved in 2018 for the treatment of metastatic melanomas with BRAF and NRAS mutations.

Research Team

Ryan Sullivan, MD

Principal Investigator

Massachusetts General Hospital

Eligibility Criteria

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.

Inclusion Criteria

I have previously been treated with or am ineligible for PD-1/PD-L1 therapy.

My solid tumor hasn't responded to standard treatments, or there are none available, or I refuse them.

My bilirubin levels are normal or slightly higher due to Gilbert's syndrome.

Exclusion Criteria

I have a muscle disorder that causes high CPK levels.

My high blood pressure is not controlled by medication.

I am not pregnant or nursing.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Phase 1b

Participants with activating mutations in the RAS pathway receive a combination of oral OKI-179 and binimetinib

1.5 years

Regular visits for monitoring and assessment

Treatment Phase 2

Participants with NRAS-mutated Melanoma receive a combination of oral OKI-179 and binimetinib

3 years

Regular visits for monitoring and assessment

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Binimetinib
• OKI-179

Trial Overview 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.

Participant Groups

Group I: OKI-179 + binimetinib Experimental Treatment 1 Intervention

Binimetinib is already approved in United States, European Union, Canada, Japan for the following indications:

Approved in United States as Mektovi for:

• Unresectable or metastatic melanoma with a BRAF V600E or V600K mutation

Approved in European Union as Mektovi for:

• Unresectable or metastatic melanoma with a BRAF V600 mutation

Approved in Canada as Mektovi for:

• Unresectable or metastatic melanoma with a BRAF V600E or V600K mutation

Approved in Japan as Mektovi for:

• Unresectable or metastatic melanoma with a BRAF V600 mutation

Who Is Running the Clinical Trial?

OnKure, Inc.

Lead Sponsor

Trials

3

Recruited

220+