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)
Rate of dose-limiting toxicities (DLTs) — DLTs will be evaluated during the first 28 days of KO-2806 treatment (dose escalation)
Descriptive statistics of adverse events (AEs) — First dose of KO-2806 up to and including 28 days after last dose of KO-2806 (dose escalation) NCI-CTCAE v5.0
Incidence of dose interruptions, reductions, and discontinuations due to AE — First dose of KO-2806 up to last dose of KO-2806 or up to 24 months of treatment (dose escalation)
Objective Response Rate (ORR) — Up to an estimated period of 24 months (dose expansion) Assessed per RECIST v1.1
Trial sites (38)
Facility
City
Region
Status
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
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.
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