KO-2806 Monotherapy and Combination Therapies in Advanced Solid Tumors

Study summary

This first-in-human (FIH) dose-escalation and dose-validation/expansion study will assess KO-2806, a farnesyltransferase inhibitor (FTI), as a monotherapy and in combination, in adult patients with advanced solid tumors.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedDarlifarnib and Cabozantinib

Plus 1 other study approaches.

Who it may be forNon-small cell lung cancer (NSCLC)

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Oct 14, 2026 · Source: ClinicalTrials.gov

Is enrollment open?Recruiting

The study is currently accepting participants.

What kind of study?Phase 1

Interventional

Where is it offered?38 U.S. locations

Locations may change over time.

Who runs it?Kura Oncology, Inc.

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Phase 1
Sponsor: Kura Oncology, Inc.
Interventions being studied: Drug: Darlifarnib; Drug: Cabozantinib; Drug: Adagrasib

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type

Non-small cell lung cancer (NSCLC)→

Treatment approach

Targeted therapy→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

At least 18 years of age.
Histologically or cytologically confirmed advanced solid tumors
Arm #1 (KO-2806 monotherapy): Patients who have progressed on, or are refractory to, standard of care (SOC) treatments with advanced solid tumors, specifically: HRAS-mutant and/or amplified tumors (any solid tumor type); HRAS overexpression (only for HNSCC tumors); KRAS and/or NRAS, and/or HRAS-mutant and/or amplified NSCLC or CRC; KRAS-mutant and/or amplified PDAC
Arm #2 (Combination): Patients who have received at least 1 prior systemic therapy with IO-based treatment for locally advanced or metastatic RCC with predominantly clear cell subtype; non-clear cell RCC patients who are either treatment-naïve or have received any prior systemic treatment for locally advanced and metastatic RCC.
Arm #3 (Combination): Patients who have received at least 1 prior systemic therapy including available approved SOC treatments for KRAS G12C-mutant locally advanced or metastatic NSCLC, CRC, or PDAC.
Arm #4 (Combination): Patients must be cabozantinib-naïve and have received at least 1 prior systemic therapy with IO-based treatment for locally advanced or metastatic ccRCC, but no more than 3 prior systemic anticancer therapies.
Arm #5 (Cabozantinib monotherapy): Patients must be cabozantinib-naïve and have received at least 1 prior systemic therapy with IO-based treatment for locally advanced or metastatic ccRCC, but no more than 3 prior systemic anticancer therapies.
Arm #6 (Cabozantinib rollover to combination): Patients must be cabozantinib-naïve and have received at least 1 prior systemic therapy with IO-based treatment for locally advanced or metastatic ccRCC, but no more than 3 prior systemic anticancer therapies.
Arm #7 (Combination): Patients who have received at least 1 prior systemic therapy including available approved SOC treatments for KRAS G12C-mutant locally advanced or metastatic NSCLC
Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Karnofsky Performance Status of 70 or higher with no clinically significant deterioration over the previous 2 weeks.
Acceptable liver, renal, endocrine, and hematologic function.
Other protocol-defined inclusion criteria may apply.

Reasons someone may not be able to joinExclusion criteria

Any use of anticancer therapy within 14 days or 5 half-lives (whichever is shorter) of Cycle 1 Day 1.
Prior treatment with an FTI or HRAS inhibitor.
Major surgery, other than local procedures, within 28 days prior to Cycle 1 Day 1, without complete recovery.
Spinal cord compression, leptomeningeal disease, or clinically active CNS metastases.
Toxicity (excluding alopecia) from prior therapy that has not been completely resolved to baseline at the time of consent.
Active or prior documented autoimmune or inflammatory disorders within the past 5 years prior to Cycle 1 Day 1 (with exceptions).
Active, uncontrolled bacterial, viral, or fungal infections requiring systemic therapy.
Inability to swallow, impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of the trial drugs.
Inadequate cardiac and/or vascular function, including receipt of treatment for unstable angina, myocardial infarction, and/or cerebrovascular attack within the prior 6 months, mean QTcF ≥470 ms, or Class II or greater congestive heart failure.
Other invasive malignancy within 2 years.
Other protocol-defined

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

Mayo Clinic Comprehensive Cancer CenterPhoenix, Arizona
University of ArizonaTucson, Arizona
University of Southern CaliforniaLos Angeles, California
Cedars-Sinai Medical CenterLos Angeles, California
UCLA Department of MedicineLos Angeles, California
Sarah Cannon Research Institute at HealthONEDenver, Colorado
AdventHealth CelebrationCelebration, Florida
Mayo Clinic Comprehensive Cancer CenterJacksonville, Florida
Florida Cancer SpecialistsSarasota, Florida
University of Iowa Hospitals & ClinicsIowa City, Iowa
Dana-Farber Cancer InstituteBoston, Massachusetts
Henry Ford Health SystemDetroit, Michigan

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Oct 14, 2026. Always confirm current availability with the study team.

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