Status:
RECRUITING
KO-2806 Monotherapy and Combination Therapies in Advanced Solid Tumors
Lead Sponsor:
Kura Oncology, Inc.
Collaborating Sponsors:
Mirati Therapeutics Inc.
Conditions:
Solid Tumors With HRAS Alterations
Non Small Cell Lung Cancer (NSCLC)
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 ad...
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.
- 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.
- 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.
- Other protocol-defined exclusion criteria may apply.
Key Trial Info
Start Date :
October 18 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2027
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT06026410
Start Date
October 18 2023
End Date
April 1 2027
Last Update
January 2 2026
Active Locations (32)
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1
Mayo Clinic Comprehensive Cancer Center
Phoenix, Arizona, United States, 85054
2
University of Southern California
Los Angeles, California, United States, 90033
3
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
4
UCLA Department of Medicine
Los Angeles, California, United States, 90095