Study of KO-2806 for Advanced Solid Tumors
This study is looking at a new drug called KO-2806, by itself and with other approved drugs like Darlifarnib, Cabozantinib, and Adagrasib. It's for adults with advanced solid tumors, including specific types like non-small cell lung cancer, colorectal cancer, and pancreatic cancer. You might be able to join if your tumor has certain genetic changes, such as HRAS alterations, or if you have specific KRAS or NRAS biomarkers. The main goals are to see how safe KO-2806 is, how well people tolerate it, and what side effects it might cause during the first 28 days of treatment and up to 24 months. The study is currently unclear about its recruitment status and plans to enroll about 300 people.
- Study design
- This is a first-in-human study that will test KO-2806 alone and in combination with other drugs. It aims to enroll about 300 participants.
- What's involved
- The study will evaluate side effects during the first 28 days of KO-2806 treatment. You will be monitored for side effects from your first dose up to 28 days after your last dose, or up to 24 months of treatment.
- Compensation
- Not stated in the trial record.
- Follow-up
- You will be monitored for adverse events from your first dose of KO-2806 up to and including 28 days after your last dose. Dose interruptions, reductions, and discontinuations due to adverse events will be tracked up to the last dose or up to 24 months of treatment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT06026410
KO-2806 Monotherapy and Combination Therapies in Advanced Solid Tumors
Recruiting
PHASE1Ages 18+InterventionalTreatmentKura Oncology, Inc.
~300 participants
Updated 2026-06-08 on ClinicalTrials.gov
What's tested:DarlifarnibCabozantinibAdagrasib
At a glance
Recruiting sites
38 of 38 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Rate of dose-limiting toxicities (DLTs)
Measured over DLTs will be evaluated during the first 28 days of KO-2806 treatment (dose escalation)
+3 more outcomes measured
Conditions
Where it's being run
38 sites across 20 statesItaly5
France4
Spain4
California3
Florida3
Germany3
Arizona2
Texas2
Who to contact
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Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
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.
Exclusion
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.
What this trial measures
- 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 AEFirst 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