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Clinical Trials in the USA / NCT06026410
Recruiting Phase 1

KO-2806 Monotherapy and Combination Therapies in Advanced Solid Tumors

NCT06026410 · tracked via the Priya Life Science USA tracker
Sponsor
Kura Oncology, Inc.
Phase
Phase 1
Started
2023-10-18
Last updated
2026-06-08

Condition(s) studied

Solid Tumors With HRAS AlterationsNon Small Cell Lung Cancer (NSCLC)Colorectal Cancer (CRC)Pancreatic Ductal Adenocarcinoma (PDAC)Clear Cell Renal Cell Carcinoma (ccRCC)Renal Cell Carcinoma (Kidney Cancer)Non Clear Cell Renal Cell Carcinoma (nccRCC)

Investigational drug(s) / intervention(s)

DarlifarnibCabozantinibAdagrasib

Darlifarnib: Oral administration

Cabozantinib: Oral administration

Adagrasib: Oral administration

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (38)

FacilityCityRegionStatus
Mayo Clinic Comprehensive Cancer Center Phoenix Arizona Recruiting
University of Arizona Tucson Arizona Recruiting
University of Southern California Los Angeles California Recruiting
Cedars-Sinai Medical Center Los Angeles California Recruiting
UCLA Department of Medicine Los Angeles California Recruiting
Sarah Cannon Research Institute at HealthONE Denver Colorado Recruiting
AdventHealth Celebration Celebration Florida Recruiting
Mayo Clinic Comprehensive Cancer Center Jacksonville Florida Recruiting
Florida Cancer Specialists Sarasota Florida Recruiting
University of Iowa Hospitals & Clinics Iowa City Iowa Recruiting
Dana-Farber Cancer Institute Boston Massachusetts Recruiting
Henry Ford Health System Detroit Michigan Recruiting
Mayo Clinic Comprehensive Cancer Center Rochester Minnesota Recruiting
Washington University School of Medicine St Louis Missouri Recruiting
Rutgers Cancer Institute of New Jersey New Brunswick New Jersey Recruiting
Ohio State University Columbus Ohio Recruiting
OU Stephenson Cancer Center Oklahoma City Oklahoma Recruiting
UPMC Hillman Cancer Center Pittsburgh Pennsylvania Recruiting
SCRI - Oncology Partners Nashville Tennessee Recruiting
UT Southwestern Simmons Cancer Center Dallas Texas Recruiting
MD Anderson Cancer Center Houston Texas Recruiting
University of Wisconsin (Carbone Cancer Center) Madison Wisconsin Recruiting
Centre Leon Berard Lyon France Recruiting
Oncologie médicale - Pitié-Salpêtrière Paris France Recruiting
Hopital Européen Georges Pompidou Paris France Recruiting
Institut Universitaire du Cancer Toulouse - Oncopole Toulouse France Recruiting
Charité - Universitätsmedizin Berlin Berlin Germany Recruiting
Universitätsklinikum Ulm Ulm Germany Recruiting
Universitätsklinikum Würzburg Würzburg Germany Recruiting
Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi IRCCS Bologna Italy Recruiting
Fondazione Piemonte per l'Oncologia - IRCCs Candiolo Candiolo Italy Recruiting
Istituto Nazionale Tumori IRCCS Naples Italy Recruiting
Humanitas University Rozzano Italy Recruiting
AOU Verona - Centro Ricerche Cliniche di Verona Verona Italy Recruiting
Hospital Universitari Vall d'Hebron Barcelona Spain Recruiting
Hospital de la Santa Creu i de Sant Pau Barcelona Spain Recruiting
Hospital HM Sanchinarro START Madrid-CIOCC Madrid Spain Recruiting
Hospital Universitario Virgen del Rocío Seville Spain Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06026410 on ClinicalTrials.gov ↗ ← All trials in the USA