KO-2806 Monotherapy and Combination Therapies in Advanced Solid Tumors
Trial Status: active
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.
Inclusion Criteria
- At least 18 years of age.
- Histologically or cytologically confirmed advanced solid tumors
- Arm #1 (Monotherapy): 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 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.
Exclusion Criteria
- Ongoing treatment with certain anticancer agents.
- 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 cerebro-vascular 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.
Additional locations may be listed on ClinicalTrials.gov for NCT06026410.
Locations matching your search criteria
United States
Arizona
Scottsdale
Mayo Clinic in Arizona
Status: Active
Name Not AvailableCalifornia
Los Angeles
UCLA / Jonsson Comprehensive Cancer Center
Status: Active
Contact: Christopher Lim
Phone: 310-633-8400
USC / Norris Comprehensive Cancer Center
Status: Active
Contact: Xiomara Menendez
Phone: 323-865-0212
Email: menendez_x@med.usc.edu
Los Angeles General Medical Center
Status: Active
Contact: Xiomara Menendez
Phone: 323-865-0212
Email: menendez_x@med.usc.edu
Florida
Jacksonville
Mayo Clinic in Florida
Status: Active
Name Not AvailableIowa
Iowa City
University of Iowa/Holden Comprehensive Cancer Center
Status: Active
Name Not AvailableMassachusetts
Boston
Dana-Farber Cancer Institute
Status: Active
Name Not AvailableBrigham and Women's Hospital
Status: Active
Name Not AvailableMinnesota
Rochester
Mayo Clinic in Rochester
Status: Active
Name Not AvailableMissouri
Saint Louis
Siteman Cancer Center at Washington University
Status: Active
Name Not AvailableNew Jersey
New Brunswick
Rutgers Cancer Institute of New Jersey
Status: Approved
Name Not AvailableOklahoma
Oklahoma City
University of Oklahoma Health Sciences Center
Status: Active
Name Not AvailablePennsylvania
Pittsburgh
University of Pittsburgh Cancer Institute (UPCI)
Status: Active
Name Not AvailableTexas
Dallas
UT Southwestern/Simmons Cancer Center-Dallas
Status: Active
Name Not AvailableHouston
M D Anderson Cancer Center
Status: Active
Name Not AvailableWisconsin
Madison
University of Wisconsin Carbone Cancer Center - Eastpark Medical Center
Status: Active
Contact: Justine Yang-Bruce
Email: jybruce@medicine.wisc.edu
University of Wisconsin Carbone Cancer Center - University Hospital
Status: Active
Name Not AvailableTrial PhasePhase I
Trial Typetreatment
Lead OrganizationKura Oncology, Inc.
- Primary IDKO-2806-001
- Secondary IDsNCI-2023-07364
- ClinicalTrials.gov IDNCT06026410