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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 developed for the treatment of solid tumors with HRAS alterations. It is currently in Phase 1 clinical development and has not been approved by the FDA. The drug is being studied in patients with advanced solid tumors that harbor HRAS mutations.
Darlifarnib targets HRAS, a protein involved in cell growth and division. As a kinase inhibitor, it is designed to interfere with HRAS signaling pathways that can drive tumor growth. This makes it a potential therapeutic option for cancers with HRAS alterations.
Darlifarnib is being developed by Kura Oncology, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol KURA. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with advanced solid tumors.
Darlifarnib is currently in Phase 1 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The ongoing Phase 1 trial is actively recruiting participants to assess the drug's safety, tolerability, and preliminary efficacy.
Darlifarnib is being evaluated in a Phase 1 clinical trial with the identifier NCT06026410. This study, titled 'KO-2806 Monotherapy and Combination Therapies in Advanced Solid Tumors,' is recruiting 300 participants across the United States, France, Germany, Italy, and Spain. The trial is open to adults aged 18 and older.
Yes, Darlifarnib is also known as KO-2806. The clinical trial NCT06026410, which evaluates Darlifarnib, is titled 'KO-2806 Monotherapy and Combination Therapies in Advanced Solid Tumors,' confirming that both names refer to the same investigational drug.