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
Status: Recruiting
Location: See all (32) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY
This first-in-human (FIH) dose-escalation and dose-validation/expansion study will assess KO-2806, a farnesyl transferase inhibitor (FTI), as a monotherapy and in combination, in adult patients with advanced solid tumors.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• At least 18 years of age.
• Histologically or cytologically confirmed advanced solid tumors
⁃ 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 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.
• 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.
Locations
United States
Arizona
Mayo Clinic Comprehensive Cancer Center
RECRUITING
Phoenix
California
Cedars-Sinai Medical Center
RECRUITING
Los Angeles
UCLA Department of Medicine
RECRUITING
Los Angeles
University of Southern California
RECRUITING
Los Angeles
Colorado
Sarah Cannon Research Institute at HealthONE
RECRUITING
Denver
Florida
AdventHealth Celebration
RECRUITING
Celebration
Mayo Clinic Comprehensive Cancer Center
RECRUITING
Jacksonville
Florida Cancer Specialists
RECRUITING
Sarasota
Iowa
University of Iowa Hospitals & Clinics
RECRUITING
Iowa City
Massachusetts
Dana-Farber Cancer Institute
RECRUITING
Boston
Michigan
Henry Ford Health System
RECRUITING
Detroit
Minnesota
Mayo Clinic Comprehensive Cancer Center
RECRUITING
Rochester
Missouri
Washington University School of Medicine
RECRUITING
St Louis
New Jersey
Rutgers Cancer Institute of New Jersey
RECRUITING
New Brunswick
Oklahoma
OU Stephenson Cancer Center
RECRUITING
Oklahoma City
Pennsylvania
UPMC Hillman Cancer Center
RECRUITING
Pittsburgh
Tennessee
SCRI - Oncology Partners
RECRUITING
Nashville
Texas
UT Southwestern Simmons Cancer Center
RECRUITING
Dallas
MD Anderson Cancer Center
RECRUITING
Houston
Wisconsin
University of Wisconsin (Carbone Cancer Center)
RECRUITING
Madison
Other Locations
France
Hopital Européen Georges Pompidou
RECRUITING
Paris
Oncologie médicale - Pitié-Salpêtrière
RECRUITING
Paris
Institut Universitaire du Cancer Toulouse - Oncopole
Fondazione Piemonte per l'Oncologia - IRCCs Candiolo
RECRUITING
Candiolo
Istituto Nazionale Tumori IRCCS
RECRUITING
Napoli
Camplus Humanitas University
RECRUITING
Rozzano
AOU Verona - Centro Ricerche Cliniche di Verona
RECRUITING
Verona
Spain
Hospital de la Santa Creu i de Sant Pau
RECRUITING
Barcelona
Hospital Universitari Vall d'Hebron
RECRUITING
Barcelona
Hospital HM Sanchinarro START Madrid-CIOCC
RECRUITING
Madrid
Hospital Universitario Virgen del Rocío
RECRUITING
Seville
Contact Information
Primary
Clinical Operations
KO-2806-001@kuraoncology.com
617-588-3755
Time Frame
Start Date:2023-10-18
Estimated Completion Date:2027-04
Participants
Target number of participants:270
Treatments
Experimental: Arm #1: RAS-altered advanced solid tumors
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
Experimental: Arm #2: Advanced or metastatic RCC
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
Experimental: Arm #3: Advanced or metastatic NSCLC, CRC, or PDAC
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