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NCT06026410PHASE1Recruiting

KO-2806 Monotherapy and Combination Therapies in Advanced Solid Tumors

Kura Oncology, Inc.

Start Date

10/18/2023

Completion Date

4/1/2027

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 Criteria

Age Range: 18 years to No maximum

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.

Interventions

DRUG

Darlifarnib

DRUG

Cabozantinib

DRUG

Adagrasib

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Conditions

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)

Locations

Mayo Clinic Comprehensive Cancer Center

Phoenix, Arizona 85054

United States

University of Arizona

Tucson, Arizona 85724

United States

University of Southern California

Los Angeles, California 90033

United States

Cedars-Sinai Medical Center

Los Angeles, California 90048

United States

UCLA Department of Medicine

Los Angeles, California 90095

United States

Sarah Cannon Research Institute at HealthONE

Denver, Colorado 80218

United States

AdventHealth Celebration

Celebration, Florida 34747

United States

Mayo Clinic Comprehensive Cancer Center

Jacksonville, Florida 32224

United States

Florida Cancer Specialists

Sarasota, Florida 34232

United States

University of Iowa Hospitals & Clinics

Iowa City, Iowa 52242

United States

Dana-Farber Cancer Institute

Boston, Massachusetts 02215

United States

Henry Ford Health System

Detroit, Michigan 48202

United States

Mayo Clinic Comprehensive Cancer Center

Rochester, Minnesota 55905

United States

Washington University School of Medicine

St Louis, Missouri 63110

United States

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey 08901

United States

Ohio State University

Columbus, Ohio 43210

United States

OU Stephenson Cancer Center

Oklahoma City, Oklahoma 73104

United States

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania 15232

United States

SCRI - Oncology Partners

Nashville, Tennessee 37203

United States

UT Southwestern Simmons Cancer Center

Dallas, Texas 75235

United States

MD Anderson Cancer Center

Houston, Texas 77030

United States

University of Wisconsin (Carbone Cancer Center)

Madison, Wisconsin 53792

United States

Centre Leon Berard

Lyon, 69495

France

Oncologie médicale - Pitié-Salpêtrière

Paris, 75013

France

Hopital Européen Georges Pompidou

Paris, 75015

France

Institut Universitaire du Cancer Toulouse - Oncopole

Toulouse, 31059

France

Charité - Universitätsmedizin Berlin

Berlin, 12203

Germany

Universitätsklinikum Ulm

Ulm, 89081

Germany

Universitätsklinikum Würzburg

Würzburg, 97080

Germany

Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi IRCCS

Bologna, 40138

Italy

Fondazione Piemonte per l'Oncologia - IRCCs Candiolo

Candiolo, 10060

Italy

Istituto Nazionale Tumori IRCCS

Naples, 80131

Italy

Humanitas University

Rozzano, 20089

Italy

AOU Verona - Centro Ricerche Cliniche di Verona

Verona, 37134

Italy

Hospital Universitari Vall d'Hebron

Barcelona, 08035

Spain

Hospital de la Santa Creu i de Sant Pau

Barcelona, 08041

Spain

Hospital HM Sanchinarro START Madrid-CIOCC

Madrid, 28050

Spain

Hospital Universitario Virgen del Rocío

Seville, 41013

Spain