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RecruitingPhase 1NCT06026410

KO-2806 Monotherapy and Combination Therapies in Advanced Solid Tumors

Trial Parameters

ConditionSolid Tumors With HRAS Alterations
SponsorKura Oncology, Inc.
Study TypeINTERVENTIONAL
PhasePhase 1
Enrollment300
SexALL
Min Age18 Years
Max AgeN/A
Start Date2023-10-18
Completion2027-01
Interventions
DarlifarnibCabozantinibAdagrasib

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Brief Summary

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 Criteria

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 NS

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