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Also known as KO-2806
Darlifarnib · 1 trial · 7 indications
NCI-CTCAE v5.0
Assessed per RECIST v1.1
| Arm | Type | Description |
|---|---|---|
| Arm #1: RAS-altered advanced solid tumors, monotherapy (escalation phase) | EXPERIMENTAL | Patients with advanced solid tumors and the following: * 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 for NSCLC or CRC * KRAS-mutant and/or amplified PDAC |
| Arm #2: Advanced or metastatic RCC, combination therapy (escalation phase) | EXPERIMENTAL | Patients who have received at least 1 prior systemic therapy with immuno-oncology (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: Advanced or metastatic NSCLC, CRC, or PDAC, combination therapy (escalation phase) | EXPERIMENTAL | Patients with KRAS G12C-mutant locally advanced or metastatic NSCLC, CRC, or PDAC who have received at least 1 prior systemic therapy including available approved standard of care treatments |
| Arm #4: Advanced or metastatic ccRCC, combination therapy (expansion phase) | EXPERIMENTAL | Patients must be cabozantinib-naïve and have received at least 1 prior systemic therapy with IO-based treatment for locally advanced or metastatic ccRCC |
| Arm #5: Advanced or metastatic ccRCC, monotherapy (expansion phase) | EXPERIMENTAL | Patients must be cabozantinib-naïve and have received at least 1 prior systemic therapy with IO-based treatment for locally advanced or metastatic ccRCC |
| Arm #6: Advanced or metastatic ccRCC, cabozantinib rollover to combination therapy (expansion phase) | EXPERIMENTAL | Patients must be cabozantinib-naïve and have received at least 1 prior systemic therapy with IO-based treatment for locally advanced or metastatic ccRCC |
| Arm #7: Advanced or metastatic NSCLC, combination therapy (expansion phase) | EXPERIMENTAL | Patients with KRAS G12C-mutant locally advanced or metastatic NSCLC who have received at least 1 prior systemic therapy including available approved standard of care treatments |
| Name | Type | Description |
|---|---|---|
| Darlifarnib | DRUG | Oral administration |
| Cabozantinib | DRUG | Oral administration |
| Adagrasib | DRUG | Oral administration |
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 ...
Darlifarnib is an investigational small molecule being studied in adults with advanced solid tumors that carry HRAS alterations. The Phase 1 program also enrolls patients with non small cell lung cancer, colorectal cancer, pancreatic ductal adenocarcinoma, and renal cell carcinoma, including both clear cell and non clear cell subtypes.
Darlifarnib targets HRAS, a member of the RAS family of signaling proteins. It is a small molecule kinase inhibitor, a class associated with the -nib naming suffix. Because the trial selects patients whose tumors carry HRAS alterations, HRAS status is used as a biomarker to identify eligible participants.
Darlifarnib is being developed by Kura Oncology, Inc., which trades on the Nasdaq under the ticker KURA. The company is running the agent as KO-2806 in a Phase 1 study evaluating monotherapy and combination regimens in advanced solid tumors.
Darlifarnib is in Phase 1 clinical development. It is investigational and has not been approved by the FDA. The single ongoing study is a controlled, open-label Phase 1 trial that is currently recruiting and is not randomized or double blinded.
Darlifarnib is being evaluated in the Phase 1 trial NCT06026410, titled KO-2806 Monotherapy and Combination Therapies in Advanced Solid Tumors. The study is recruiting up to 300 participants aged 18 and older across the United States, France, Germany, Italy, and Spain, and it does not enroll healthy volunteers.
Yes. Darlifarnib is also known as KO-2806, the code name used in its clinical trial listing. Both names refer to the same HRAS-targeted small molecule kinase inhibitor that Kura Oncology is developing in the Phase 1 NCT06026410 study for HRAS-altered advanced solid tumors.