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
- Berlin, Ulm, and Wuerzburg, GermanySee the 3 sites
- Phase
- Phase 1
Where in Germany
- Charite Universitaetsmedizin Berlin KöRBerlin, GermanyTaking people
- Universitaetsklinikum Ulm AoRUlm, GermanyTaking people
- Universitaetsklinikum Wuerzburg AöRWuerzburg, GermanyTaking 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.