KO-2806 Monotherapy and Combination Therapies in Advanced Solid Tumors
NCT ID: NCT06026410
Last Updated: 2026-01-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
300 participants
INTERVENTIONAL
2023-10-18
2027-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Arm #1: RAS-altered advanced solid tumors, monotherapy (escalation phase)
Patients with advanced solid tumors and the following:
* 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 for NSCLC or CRC
* KRAS-mutant and/or amplified PDAC
Darlifarnib
Oral administration
Arm #2: Advanced or metastatic RCC, combination therapy (escalation phase)
Patients who have received at least 1 prior systemic therapy with immuno-oncology (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
Darlifarnib
Oral administration
Cabozantinib
Oral administration
Arm #3: Advanced or metastatic NSCLC, CRC, or PDAC, combination therapy (escalation phase)
Patients with KRAS G12C-mutant locally advanced or metastatic NSCLC, CRC, or PDAC who have received at least 1 prior systemic therapy including available approved standard of care treatments
Darlifarnib
Oral administration
Adagrasib
Oral administration
Arm #4: Advanced or metastatic ccRCC, combination therapy (expansion phase)
Patients must be cabozantinib-naïve and have received at least 1 prior systemic therapy with IO-based treatment for locally advanced or metastatic ccRCC
Darlifarnib
Oral administration
Cabozantinib
Oral administration
Arm #5: Advanced or metastatic ccRCC, monotherapy (expansion phase)
Patients must be cabozantinib-naïve and have received at least 1 prior systemic therapy with IO-based treatment for locally advanced or metastatic ccRCC
Cabozantinib
Oral administration
Arm #6: Advanced or metastatic ccRCC, cabozantinib rollover to combination therapy (expansion phase)
Patients must be cabozantinib-naïve and have received at least 1 prior systemic therapy with IO-based treatment for locally advanced or metastatic ccRCC
Darlifarnib
Oral administration
Cabozantinib
Oral administration
Arm #7: Advanced or metastatic NSCLC, combination therapy (expansion phase)
Patients with KRAS G12C-mutant locally advanced or metastatic NSCLC who have received at least 1 prior systemic therapy including available approved standard of care treatments
Darlifarnib
Oral administration
Adagrasib
Oral administration
Interventions
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Darlifarnib
Oral administration
Cabozantinib
Oral administration
Adagrasib
Oral administration
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Mirati Therapeutics Inc.
INDUSTRY
Kura Oncology, Inc.
INDUSTRY
Responsible Party
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Locations
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Mayo Clinic Comprehensive Cancer Center
Phoenix, Arizona, United States
University of Southern California
Los Angeles, California, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
UCLA Department of Medicine
Los Angeles, California, United States
Sarah Cannon Research Institute at HealthONE
Denver, Colorado, United States
AdventHealth Celebration
Celebration, Florida, United States
Mayo Clinic Comprehensive Cancer Center
Jacksonville, Florida, United States
Florida Cancer Specialists
Sarasota, Florida, United States
University of Iowa Hospitals & Clinics
Iowa City, Iowa, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Henry Ford Health System
Detroit, Michigan, United States
Mayo Clinic Comprehensive Cancer Center
Rochester, Minnesota, United States
Washington University School of Medicine
St Louis, Missouri, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
OU Stephenson Cancer Center
Oklahoma City, Oklahoma, United States
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
SCRI - Oncology Partners
Nashville, Tennessee, United States
UT Southwestern Simmons Cancer Center
Dallas, Texas, United States
MD Anderson Cancer Center
Houston, Texas, United States
University of Wisconsin (Carbone Cancer Center)
Madison, Wisconsin, United States
Oncologie médicale - Pitié-Salpêtrière
Paris, , France
Hopital Européen Georges Pompidou
Paris, , France
Institut Universitaire du Cancer Toulouse - Oncopole
Toulouse, , France
Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi IRCCS
Bologna, , Italy
Fondazione Piemonte per l'Oncologia - IRCCs Candiolo
Candiolo, , Italy
Istituto Nazionale Tumori IRCCS
Napoli, , Italy
Camplus Humanitas University
Rozzano, , Italy
AOU Verona - Centro Ricerche Cliniche di Verona
Verona, , Italy
Hospital Universitari Vall d'Hebron
Barcelona, , Spain
Hospital de la Santa Creu i de Sant Pau
Barcelona, , Spain
Hospital HM Sanchinarro START Madrid-CIOCC
Madrid, , Spain
Hospital Universitario Virgen del Rocío
Seville, , Spain
Countries
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Central Contacts
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Facility Contacts
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Role: primary
Mimi McKay
Role: primary
Role: primary
Other Identifiers
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KO-2806-001
Identifier Type: -
Identifier Source: org_study_id
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