← Back to searchRecruitingRecruiting
KO-2806 Monotherapy and Combination Therapies in Advanced Solid Tumors
NCT06026410 · Kura Oncology, Inc.
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
Phase 1, First-in-Human, Multicenter, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of KO-2806 When Administered as Monotherapy and in Combination Therapy in Adult Patients With Advanced Solid Tumors
About this study
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.
Eligibility criteria
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.
Study design
Enrollment target: 300 participants
Allocation: non_randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2023-10-18
Estimated completion: 2027-04
Last updated: 2026-04-14
Interventions
Drug: DarlifarnibDrug: CabozantinibDrug: Adagrasib
Primary outcomes
- • Rate of dose-limiting toxicities (DLTs) (DLTs will be evaluated during the first 28 days of KO-2806 treatment (dose escalation))
- • Descriptive statistics of adverse events (AEs) (First dose of KO-2806 up to and including 28 days after last dose of KO-2806 (dose escalation))
- • Incidence of dose interruptions, reductions, and discontinuations due to AE (First dose of KO-2806 up to last dose of KO-2806 or up to 24 months of treatment (dose escalation))
Sponsor
Kura Oncology, Inc. · industry
With: Mirati Therapeutics Inc.
Contacts & investigators
ContactKura Medical Information · contact · medinfo@kuraoncology.com · 844-KURAONC (844-587-2662)
All locations (40)
Mayo Clinic Comprehensive Cancer CenterRecruiting
Phoenix, Arizona, United States
University of ArizonaRecruiting
Tucson, Arizona, United States
University of ArizonaRecruiting
Tucson, Arizona, United States
University of Southern CaliforniaRecruiting
Los Angeles, California, United States
Cedars-Sinai Medical CenterRecruiting
Los Angeles, California, United States
UCLA Department of MedicineRecruiting
Los Angeles, California, United States
Sarah Cannon Research Institute at HealthONERecruiting
Denver, Colorado, United States
AdventHealth CelebrationRecruiting
Celebration, Florida, United States
Mayo Clinic Comprehensive Cancer CenterRecruiting
Jacksonville, Florida, United States
Florida Cancer SpecialistsRecruiting
Sarasota, Florida, United States
University of Iowa Hospitals & ClinicsRecruiting
Iowa City, Iowa, United States
Dana-Farber Cancer InstituteRecruiting
Boston, Massachusetts, United States
Henry Ford Health SystemRecruiting
Detroit, Michigan, United States
Mayo Clinic Comprehensive Cancer CenterRecruiting
Rochester, Minnesota, United States
Washington University School of MedicineRecruiting
St Louis, Missouri, United States
Rutgers Cancer Institute of New JerseyRecruiting
New Brunswick, New Jersey, United States
Ohio State UniversityRecruiting
Columbus, Ohio, United States
OU Stephenson Cancer CenterRecruiting
Oklahoma City, Oklahoma, United States
UPMC Hillman Cancer CenterRecruiting
Pittsburgh, Pennsylvania, United States
SCRI - Oncology PartnersRecruiting
Nashville, Tennessee, United States
UT Southwestern Simmons Cancer CenterRecruiting
Dallas, Texas, United States
MD Anderson Cancer CenterRecruiting
Houston, Texas, United States
University of Wisconsin (Carbone Cancer Center)Recruiting
Madison, Wisconsin, United States
Centre Leon BerardRecruiting
Lyon, France
Oncologie médicale - Pitié-SalpêtrièreRecruiting
Paris, France
Hopital Européen Georges PompidouRecruiting
Paris, France
Institut Universitaire du Cancer Toulouse - OncopoleRecruiting
Toulouse, France
Charité - Universitätsmedizin BerlinRecruiting
Berlin, Germany
Charité - Universitätsmedizin BerlinRecruiting
Berlin, Germany
Universitätsklinikum UlmRecruiting
Ulm, Germany
Universitätsklinikum WürzburgRecruiting
Würzburg, Germany
Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi IRCCSRecruiting
Bologna, Italy
Fondazione Piemonte per l'Oncologia - IRCCs CandioloRecruiting
Candiolo, Italy
Istituto Nazionale Tumori IRCCSRecruiting
Naples, Italy
Humanitas UniversityRecruiting
Rozzano, Italy
AOU Verona - Centro Ricerche Cliniche di VeronaRecruiting
Verona, Italy
Hospital Universitari Vall d'HebronRecruiting
Barcelona, Spain
Hospital de la Santa Creu i de Sant PauRecruiting
Barcelona, Spain
Hospital HM Sanchinarro START Madrid-CIOCCRecruiting
Madrid, Spain
Hospital Universitario Virgen del RocíoRecruiting
Seville, Spain