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New treatment option for Solid Tumors With HRAS Alterations
Official title KO-2806 Monotherapy and Combination Therapies in Advanced Solid Tumors
ClinicalTrials.gov ID: NCT06026410
What this study is testing
What is Darlifarnib?
Darlifarnib is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for solid tumors with hras alterations.
Also referred to as KO-2806.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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...
- Arm #2 (Combination): Patients who have received at least 1 prior systemic therapy with IO-based treatment for locally advanced or metastatic RCC...
- Arm #3 (Combination): Patients who have received at least 1 prior systemic therapy including available approved SOC treatments for KRAS G12C-mutant...
You likely can't join 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).
See the full eligibility 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...
- 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...
- 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...
- 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...
- 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...
- 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 may apply.
- 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...
- Other invasive malignancy within 2 years.
- Other protocol-defined exclusion criteria may apply.
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
- Tucson, Arizona, United States
- Los Angeles, California, United States
- Denver, Colorado, United States
- Celebration, Florida, United States
- Jacksonville, Florida, United States
- Sarasota, Florida, United States
- Iowa City, Iowa, United States
- Boston, Massachusetts, United States
- Detroit, Michigan, United States
- Rochester, Minnesota, United States
- St Louis, Missouri, United States
- New Brunswick, New Jersey, United States
- Columbus, Ohio, United States
- Oklahoma City, Oklahoma, United States
- Pittsburgh, Pennsylvania, United States
- Nashville, Tennessee, United States
- Dallas, Texas, United States
- Houston, Texas, United States
- Madison, Wisconsin, United States
+ 14 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Phoenix, Arizona, United States; Tucson, Arizona, United States; Los Angeles, California, United States; Denver, Colorado, United States; Celebration, Florida, United States; Jacksonville, Florida, United States and 28 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.