RAS MutationPhase 1/2NCT05340621
NAUTILUS: OKI-179 Plus Binimetinib in Patients with Advanced Solid Tumors in the RAS Pathway (Phase 1b) and NRAS-mutated Melanoma (Phase 2)
A Phase 1/2 study testing OKI-179 + binimetinib in people with RAS Mutation and NRAS Gene Mutation, run by OnKure, Inc. at 12 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- RAS Mutation, NRAS Gene Mutation, Melanoma
- What is being tested?
- OKI-179 + binimetinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 12 sitesUnited States
- Study dates
- 11 May 2022to 29 Jan 2025
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Phase 1b: Prior MEK inhibitor exposure may be allowed per Sponsor agreement
- Phase 2: Histologically confirmed, metastatic melanoma with a confirmed NRAS mutation determined by a validated NRAS mutation detection kit performed in a Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory
- 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 2: Consent for a tumor biopsy or can provide a recent archival tumor biopsy sample (within 2 years)
Show all 19Show fewer
- Phase 2: At least 1 measurable lesion based on RECIST version 1.1
- Eastern Cooperative Oncology Group performance status of 0 or 1
- Normal organ and marrow function as defined below:
- Absolute neutrophil count ≥ 1.5 × 109/L
- Platelets ≥ 100,000/μL
- Hemoglobin ≥ 9.0 g/dL (at least 1 week after packed red blood cells, if applicable)
- Total bilirubin within institutional ULN, unless patient has Gilbert's syndrome and has total bilirubin ≤ 2.5 × institutional ULN
- Alanine aminotransferase and aspartate aminotransferase ≤ 2.5 × institutional ULN or < 5 × institutional ULN in the presence of liver metastasis
- Serum creatinine < 1.5 × institutional ULN
- All prior treatment-related toxicities must have resolved to CTCAE version 5.0 criteria of Grade ≤ 1, except for alopecia and ICI-related endocrinopathies managed with hormone replacement therapy (eg, thyroiditis/hypothyroidism, hypophysitis, diabetes mellitus type 1)
- Left ventricular ejection fraction (LVEF) ≥ 50%
- Able to swallow and tolerate oral medications
- Life expectancy ≥ 3 months
Who cannot join
- Any of the prior treatments, as described below:
- Major surgery within 28 days of C1D1
- Chemotherapy or radiation within 2 weeks of C1D1
- Investigational agents within 4 weeks of C1D1 or < 5 half-lives, whichever is shorter, or expected toxicity not resolved to CTCAE version 5.0 criteria of Grade ≤ 1, except for alopecia and ICI-related endocrinopathies managed with hormone replacement therapy
- Prior histone deacetylases inhibitors, MEK inhibitors (Phase 2 only), pan-deacetylating agents, or valproic acid for the treatment of cancer
- Untreated or symptomatic brain metastasis. Patients with previously treated brain metastasis who are not on corticosteroids and are clinically stable are eligible for enrollment, as are patients with small (< 0.5 cm) untreated and asymptomatic brain metastases
Show all 25Show fewer
- Known hypersensitivity to binimetinib or other MEK inhibitors
- Women who are pregnant or nursing
- Concomitant active malignancies or previous malignancies with < 2-year disease-free interval at the time of enrollment. Patients with adequately resected basal or squamous cell carcinoma of the skin, carcinoma in situ of the cervix or breast, stage 1 prostate cancer, or other malignancies deemed to be cured by prior therapy in the judgment of the Investigator may enroll irrespective of the time of diagnosis
- Any severe concurrent medical or psychiatric condition (including active systemic infection requiring intravenous antibiotics, uncontrolled diabetes mellitus, symptomatic congestive heart failure, uncontrolled hypertension, or cardiac arrhythmia) which, in the judgment of the Investigator, would make the patient inappropriate for study participation
- Impaired cardiovascular function or clinically significant cardiovascular diseases, including any of the following:
- History of acute myocardial infarction, acute coronary syndromes (including unstable angina, coronary artery bypass graft, coronary angioplasty or stenting) < 6 months prior to start of study treatment
- Symptomatic congestive heart failure (Grade 2 or higher), history or current evidence of clinically significant cardiac arrhythmia and/or conduction abnormality < 6 months prior to the start of study treatment, except medically managed atrial fibrillation or paroxysmal supraventricular tachycardia
- Uncontrolled arterial hypertension despite medical management
- History or evidence of central serous retinopathy (CSR), retinal vein occlusion (RVO) or any eye condition that would be considered a risk factor for CSR or RVO, such as uncontrolled glaucoma or ocular hypertension
- Known previous or current serious ophthalmic disease, history of cataract surgery within < 8 days, serious eye trauma, or intraocular or ocular surgery other than refractive surgery (i.e. LASIK, cataract); patients with uveal melanoma/eye enucleation due to uveal melanoma are permitted to enroll
- 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)
- History of recent (≤ 90 days) thromboembolic or cerebrovascular event such as transient ischemic attack, cerebrovascular accident, or hemodynamically significant (massive or submassive) deep vein thrombosis or pulmonary emboli (DVT/PE). Note: Patients with DVT/PE that does not result in hemodynamic instability may enroll as long as they are anticoagulated for at least 4 weeks. Note: Patients with DVT/PE related to indwelling catheters or other procedures may enroll
- Any medical condition that would impair the administration of oral agents, such as active inflammatory bowel disease or uncontrolled nausea, vomiting, or diarrhea
- 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
- History or current evidence of congenital long QT syndrome
- QTcF corrected with Fridericia's formula > 470 msec on screening electrocardiogram (ECG)
- Ongoing medication that leads to significant QT prolongation
- Ongoing medication that is a strong cytochrome P450 3A4 inhibitor or inducer
- Ongoing medication that is a strong inhibitor of P-glycoprotein and sensitive substrates
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Emory University Winship Cancer Institute
Atlanta, Georgia, 30322
Massachusetts General Hospital
Boston, Massachusetts, 02114
University of Virginia Health System
Charlottesville, Virginia, 22908
Henry Ford Health System
Detroit, Michigan, 48202
University of Florida Health Cancer Center
Gainesville, Florida, 32610
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065
CTCA Atlanta, part of City of Hope
Newnan, Georgia, 30265
CTCA Phoenix, part of City of Hope
Phoenix, Arizona, 85027
University of California, San Francisco
San Francisco, California, 94143
CTCA Chicago, part of City of Hope
Zion, Illinois, 60099
About this study
Official title: 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)
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
- Being tested
- OKI-179 + binimetinib
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OKI-179 + binimetinibDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| OKI-179 + binimetinib | Experimental | Not described Receives: Drug: OKI-179 + binimetinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1b: Incidence and severity of dose-limiting toxicities (DLTs)
Incidence and severity of DLTs will be measured in the DLT-evaluable population during Cycle 1.
Measured: First 28 days of treatment
Phase 1b: Incidence and severity of adverse events (AEs)
AEs will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Measured: Phase 1b study duration (approximately 1.5 years)
Phase 1b: Change in clinical laboratory abnormalities
Changes from baseline through study treatment will be analyzed using NCI CTCAE version 5.0 grade criteria
Measured: Baseline through 30 days after end of study treatment
Phase 1b: Change in Eastern Cooperative Oncology Group (ECOG) performance status
Measured: Phase 1b study duration (approximately 1.5 years)
Phase 2: Objective response rate (ORR)
Objective responses will be determined per RECIST version 1.1 criteria, and the ORR will be defined as the proportion of patients with the best overall confirmed response of complete response (CR) or partial response (PR) in the Efficacy-Evaluable Population
Measured: Phase 2 study duration (approximately 3 years)
Secondary outcomes (11)
Phase 1b: Peak plasma concentration (Cmax) of OKI-179 and OKI-006
PK parameters will be measured based on plasma concentration-time data of OKI-179 and OKI-006
Measured: First 28 days of treatment
Phase 1b: Area Under the Plasma Concentration vs. Time Curve (AUC) of OKI-179 and OKI-006
PK parameters will be measured based on plasma concentration-time data of OKI-179 and OKI-006
Measured: First 28 days of treatment
Phase 1b: Objective response rate (ORR)
Objective responses will be determined per RECIST version 1.1 criteria, and the ORR will be defined as the proportion of patients with the best overall confirmed response of complete response (CR) or partial response (PR) in the Efficacy-Evaluable Population.
Measured: Phase 1b study duration (approximately 1.5 years)
Phase 1b: Clinical Benefit Rate (CBR)
Clinical benefit will be defined as the best overall confirmed response of CR, PR or stable disease for at least 3 months. The CBR will be defined as the proportion of patients with clinical benefit in the Efficacy-Evaluable Population.
Measured: Phase 1b study duration (approximately 1.5 years)
Phase 1b: Duration of Response (DOR)
The DOR will be calculated for all patients achieving a confirmed CR or PR and will be defined as the time from first disease assessment of PR or CR (whichever is first recorded) to the end of response, defined as occurrence of PD, death due to any cause, or relapse from CR.
Measured: Phase 1b study duration (approximately 1.5 years)
Phase 2: Peak plasma concentration (Cmax) of OKI-179 and OKI-006
PK parameters will be measured based on plasma concentration-time data of OKI-179 and OKI-006
Measured: First 28 days of treatment
Phase 2: Area Under the Plasma Concentration vs. Time Curve (AUC) of OKI-179 and OKI-006
PK parameters will be measured based on plasma concentration-time data of OKI-179 and OKI-006
Measured: First 28 days of treatment
Phase 2: Progression-free survival (PFS)
Progression-free survival will be defined as the time from the first administration of OKI-179 to the date of progression or death due to any cause.
Measured: Phase 2 study duration (approximately 3 years)
Phase 2: Clinical Benefit Rate
Clinical benefit will be defined as the best overall confirmed response of CR, PR or stable disease for at least 3 months. The CBR will be defined as the proportion of patients with clinical benefit in the Efficacy-Evaluable Population.
Measured: Phase 2 study duration (approximately 3 years)
Phase 2: Duration of Response
The DOR will be calculated for all patients achieving a confirmed CR or PR and will be defined as the time from first disease assessment of PR or CR (whichever is first recorded) to the end of response, defined as occurrence of PD, death due to any cause, or relapse from CR.
Measured: Phase 2 study duration (approximately 3 years)
Phase 2: Incidence and severity of AEs
AEs will be graded according to the NCI CTCAE version 5.0
Measured: Phase 2 study duration (approximately 3 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2022
- Study start11 May 2022
- Primary completion29 Jan 2025
- Study completion29 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RAS MutationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- OnKure, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ryan Sullivan, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05340621
- Sponsor's protocol ID
- OKI-179-230
- Status last verified
- Mar 2025
- First submitted
- 22 Feb 2022
- Last updated
- 7 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT05340621
- Acronym / sponsor ID
- OKI-179-230
- Conditions
- RAS Mutation, NRAS Gene Mutation, Melanoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- OnKure, Inc.Industry (pharma, biotech, devices)
- Study start
- 11 May 2022 (actual)
- Primary completion
- 29 Jan 2025 (actual)
- Study completion
- 29 Jan 2025 (actual)
- First posted
- 22 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OKI-179 + binimetinib | Experimental | Drug: OKI-179 + binimetinib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- 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
- Phase 1b: Prior MEK inhibitor exposure may be allowed per Sponsor agreement
- Phase 2: Histologically confirmed, metastatic melanoma with a confirmed NRAS mutation determined by a validated NRAS mutation detection kit performed in a Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory
- 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
Key exclusion criteria (25 listed)
- Any of the prior treatments, as described below:
- Known hypersensitivity to binimetinib or other MEK inhibitors
- Women who are pregnant or nursing
- Concomitant active malignancies or previous malignancies with < 2-year disease-free interval at the time of enrollment. Patients with adequately resected basal or squamous cell carcinoma of the skin, carcinoma in situ of the cervix or breast, stage 1 prostate cancer, or other malignancies deemed to be cured by prior therapy in the judgment of the Investigator may enroll irrespective of the time of diagnosis
- Any severe concurrent medical or psychiatric condition (including active systemic infection requiring intravenous antibiotics, uncontrolled diabetes mellitus, symptomatic congestive heart failure, uncontrolled hypertension, or cardiac arrhythmia) which, in the judgment of the Investigator, would make the patient inappropriate for study participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OKI-179 + binimetinibPhase 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. | Drug | OKI-179 + binimetinib |
Primary outcome
Phase 1b: Incidence and severity of dose-limiting toxicities (DLTs)
Time frame: First 28 days of treatment
Incidence and severity of DLTs will be measured in the DLT-evaluable population during Cycle 1.
Phase 1b: Incidence and severity of adverse events (AEs)
Time frame: Phase 1b study duration (approximately 1.5 years)
AEs will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Phase 1b: Change in clinical laboratory abnormalities
Time frame: Baseline through 30 days after end of study treatment
Changes from baseline through study treatment will be analyzed using NCI CTCAE version 5.0 grade criteria
Phase 1b: Change in Eastern Cooperative Oncology Group (ECOG) performance status
Time frame: Phase 1b study duration (approximately 1.5 years)
Phase 2: Objective response rate (ORR)
Time frame: Phase 2 study duration (approximately 3 years)
Objective responses will be determined per RECIST version 1.1 criteria, and the ORR will be defined as the proportion of patients with the best overall confirmed response of complete response (CR) or partial response (PR) in the Efficacy-Evaluable Population
11 secondary outcomes
Phase 1b: Peak plasma concentration (Cmax) of OKI-179 and OKI-006
Time frame: First 28 days of treatment
Phase 1b: Area Under the Plasma Concentration vs. Time Curve (AUC) of OKI-179 and OKI-006
Time frame: First 28 days of treatment
Phase 1b: Objective response rate (ORR)
Time frame: Phase 1b study duration (approximately 1.5 years)
Phase 1b: Clinical Benefit Rate (CBR)
Time frame: Phase 1b study duration (approximately 1.5 years)
Phase 1b: Duration of Response (DOR)
Time frame: Phase 1b study duration (approximately 1.5 years)
Phase 2: Peak plasma concentration (Cmax) of OKI-179 and OKI-006
Time frame: First 28 days of treatment
Phase 2: Area Under the Plasma Concentration vs. Time Curve (AUC) of OKI-179 and OKI-006
Time frame: First 28 days of treatment
Phase 2: Progression-free survival (PFS)
Time frame: Phase 2 study duration (approximately 3 years)
Phase 2: Clinical Benefit Rate
Time frame: Phase 2 study duration (approximately 3 years)
Phase 2: Duration of Response
Time frame: Phase 2 study duration (approximately 3 years)
Phase 2: Incidence and severity of AEs
Time frame: Phase 2 study duration (approximately 3 years)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ryan Sullivan, MD principal investigator
Massachusetts General Hospital
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing OKI-179 + binimetinib in people with RAS Mutation and NRAS Gene Mutation, run by OnKure, Inc. at 12 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase 1b: Incidence and severity of dose-limiting toxicities (DLTs) (time frame: First 28 days of treatment). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2025.