RecruitingPhase 1NCT06026410

KO-2806 Monotherapy and Combination Therapies in Advanced Solid Tumors

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

Sponsor

Kura Oncology, Inc.

Enrollment

300 participants

Start Date

Oct 18, 2023

Study Type

INTERVENTIONAL

Conditions

Solid Tumors With HRAS Alterations

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called KO-2806 — alone and in combination with other cancer drugs — for people with various advanced solid tumors. KO-2806 targets proteins called HRAS, KRAS, and NRAS that are often mutated in certain cancers, making them keep growing unchecked. The study has multiple arms covering different cancer types. **You may be eligible if...** - You are 18 or older with an advanced solid tumor that has progressed after standard treatments - Your cancer has specific genetic mutations (e.g., HRAS, KRAS, NRAS) depending on the trial arm - Your tumor type may include head and neck cancer, lung cancer, colon cancer, pancreatic cancer, or kidney cancer - Your heart, liver, and kidneys are functioning adequately **You may NOT be eligible if...** - You have untreated or active brain metastases or leptomeningeal disease (cancer in the fluid around the brain) - You have received cancer treatment in the past 14 days - You have previously received an HRAS inhibitor or farnesyl transferase inhibitor - You have had a heart attack or stroke in the last 6 months Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGDarlifarnib

Oral administration

DRUGCabozantinib

Oral administration

DRUGAdagrasib

Oral administration

Locations(40)

Mayo Clinic Comprehensive Cancer Center

Phoenix, Arizona, United States

University of Arizona

Tucson, Arizona, United States

University of Arizona

Tucson, 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

Ohio State University

Columbus, Ohio, 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

Centre Leon Berard

Lyon, France

Oncologie médicale - Pitié-Salpêtrière

Paris, France

Hopital Européen Georges Pompidou

Paris, France

Institut Universitaire du Cancer Toulouse - Oncopole

Toulouse, France

Charité - Universitätsmedizin Berlin

Berlin, Germany

Charité - Universitätsmedizin Berlin

Berlin, Germany

Universitätsklinikum Ulm

Ulm, Germany

Universitätsklinikum Würzburg

Würzburg, Germany

Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi IRCCS

Bologna, Italy

Fondazione Piemonte per l'Oncologia - IRCCs Candiolo

Candiolo, Italy

Istituto Nazionale Tumori IRCCS

Naples, Italy

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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06026410