RecruitingSolid Tumors With HRAS AlterationsNon Small Cell Lung Cancer (NSCLC)Colorectal Cancer (CRC)

KO-2806 Monotherapy and Combination Therapies in Advanced Solid Tumors

Eligible age

18+ yrs

Accepts

All genders

Locations

16 states

Healthy volunteers

See if you qualify for this study

Answer a few quick questions about your location and health. Takes about a minute.

Check my eligibility →

About this study

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.

Sponsor: Kura Oncology, Inc.

You may qualify if…

✓ 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.

You may not qualify if…

✕ 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.