Tests KO-2806 alone and combined with other drugs in advanced solid tumors
Tests KO-2806 alone and with other drugs in adults with advanced solid tumors.
Plain-language title generated from the registry record
Registry title: KO-2806 Monotherapy and Combination Therapies in Advanced Solid Tumors
Key facts
- Where
- Barcelona, Madrid, and Sevilla, SpainSee the 4 sites
- Phase
- Phase 1
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with advanced solid tumors, such as lung, colorectal, pancreatic or kidney cancer, whose disease has progressed after earlier treatment. It tests KO-2806 alone and with other drugs.
- Age
- 18 years or older.
- Sex
- All sexes can join.
- Disease stage
- Advanced or metastatic solid tumors that can be measured by RECIST v1.1. Types include HRAS-mutant tumors, NSCLC, CRC, PDAC and kidney cancer (clear cell or non-clear cell).
- Earlier treatment
- Depends on the arm. Most arms need at least 1 earlier systemic treatment, and some need earlier immunotherapy-based treatment. Some arms allow no more than 3 earlier anticancer therapies. Some arms need people who have never taken cabozantinib. Earlier treatment with an FTI or HRAS inhibitor is not allowed.
- Biomarker or test result
- Depends on the arm. HRAS-mutant and/or amplified tumors; KRAS, NRAS and/or HRAS changes in NSCLC or CRC; KRAS-mutant and/or amplified PDAC; HRAS overexpression for head and neck tumors only; KRAS G12C mutation for some combination arms.
Main reasons for not taking part
- Anticancer therapy within 14 days or 5 half-lives before starting
- Earlier treatment with an FTI or HRAS inhibitor
- Spinal cord compression, leptomeningeal disease or active brain metastases
- Heart problems, including a heart attack or stroke in the past 6 months
- Another invasive cancer within 2 years
Read by machine on 9 November 2026.
Where in Spain
- Hospital de la Santa Creu i Sant PauBarcelona, SpainTaking people
- Hospital Universitari Vall d'HebronBarcelona, SpainTaking people
- Hospital Universitario HM SanchinarroMadrid, SpainTaking people
- University Hospital Virgen Del Rocio S.L.Sevilla, SpainTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Kura Oncology, Inc.
- Trial code
- NCT06026410EU 2024-513285-19-00
- Record updated
- 14 October 2026
- Original description
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.Read full original descriptionShow less
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
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.
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; Other protocol-defined inclusion criteria may apply.
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; 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); 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; Spinal cord compression, leptomeningeal disease, or clinically active CNS metastases; 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; Other invasive malignancy within 2 years; Other protocol-defined exclusion criteria may apply.