RecruitingPhase 1NCT06026410

KO-2806 Monotherapy and Combination Therapies in Advanced Solid Tumors

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.

Checked against the public recordLast updated Jun 8, 2026 · Source: ClinicalTrials.gov

StatusRecruiting
PhasePhase 1
U.S. locations38
SponsorKura Oncology, Inc.
01
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
02
Explore related studies

How this study is categorized

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

03
Public criteria

Who may be able to participate

Inclusion 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. Exclusion 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 exclusion criteria may apply.

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

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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: Jun 8, 2026. Always confirm current availability with the study team.

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