Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06026410 | KO-2806 Monotherapy and Combination Therapies in Advanced Solid Tumors | PHASE1 | RECRUITING | 300 | — | — | Oct 18, 2023 | Apr 1, 2027 | Jun 8, 2026 | 38 | United States, France +3 |
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 ...