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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04620330 | A Study of Avutometinib (VS-6766) + Defactinib in Recurrent KRAS G12V, Other KRAS and BRAF Non-Small Cell Lung Cancer | PHASE2 | COMPLETED | 90 | — | — | Dec 31, 2020 | Dec 12, 2023 | Jan 12, 2024 | 45 | United States, France +3 |
| NCT05375994 | Study of Avutometinib (VS-6766) + Adagrasib in KRAS G12C NSCLC Patients | PHASE1 | ACTIVE NOT_RECRUITING | 85 | — | — | Aug 1, 2022 | Jan 1, 2026 | May 18, 2025 | 8 | United States |
| NCT05074810 | Phase 1/2 Study of Avutometinib (VS-6766) + Sotorasib With or Without Defactinib in KRAS G12C NSCLC Patients | PHASE1 | ACTIVE NOT_RECRUITING | 153 | — | — | Apr 12, 2022 | Apr 1, 2027 | Jan 12, 2026 | 35 | United States, Belgium +4 |
Confirmed overall response rate per RECIST 1.1
Confirmed overall response rate per RECIST 1.1
Confirmed overall response rate per RECIST 1.1
Confirmed overall response rate per RECIST 1.1
Assessment of Dose-limiting toxicities (DLTs)
Confirmed overall response rate per RECIST 1.1
Assessment of Dose-limiting toxicities (DLTs)
Confirmed overall response rate per RECIST 1.1
| Arm | Type | Description |
|---|---|---|
| Arm 1: avutometinib (VS-6766) monotherapy | EXPERIMENTAL | in patients with NSCLC KRAS-G12V tumor |
| Arm 2: avutometinib (VS-6766) in combination with defactinib | EXPERIMENTAL | in patients with a NSCLC KRAS-G12V tumor |
| Arm 3: avutometinib (VS-6766) in combination with defactinib | EXPERIMENTAL | in patients with a NSCLC KRAS-other (non-G12V) tumor |
| Arm 4: avutometinib (VS-6766) in combination with defactinib | EXPERIMENTAL | in patients with a NSCLC BRAF-V600E tumor |
| Arm 5:avutometinib (VS-6766) in combination with defactinib | EXPERIMENTAL | in patients with a NSCLC BRAF-non-V600E tumor |
| avutometinib(VS-6766)+adagrasib | EXPERIMENTAL | To determine the recommended phase 2 dose (RP2D) for VS-6766 in combination with adagrasib in G12C inhibitor exposed patients |
| avutometinib (VS-6766)+adagrasib RP2D | EXPERIMENTAL | To determine the efficacy of the RP2D identified from Part A in G12C inhibitor exposed patients |
| avutometinib (VS-6766)+sotorasib | EXPERIMENTAL | To determine the recommended phase 2 dose (RP2D) for avutometinib (VS 6766) in combination with sotorasib in KRAS G12C inhibitor naïve and exposed patients |
| avutometinib (VS-6766)+sotorasib - KRAS G12C inhibitor naïve | EXPERIMENTAL | To determine the efficacy of the RP2D identified from Part A in KRAS G12C inhibitor naïve patients |
| avutometinib (VS-6766)+sotorasib - KRAS G12C inhibitor exposed | EXPERIMENTAL | To determine the efficacy of the RP2D identified from Part A in KRAS G12C inhibitor exposed patients |
| avutometinib (VS-6766)+sotorasib+defactinib | EXPERIMENTAL | To determine the recommended phase 2 dose (RP2D) for avutometinib (VS-6766) in combination with sotorasib and defactinib in KRAS G12C inhibitor exposed patients |
| avutometinib (VS-6766)+sotorasib+defactinib - KRAS G12C inhibitor naive | EXPERIMENTAL | To determine the efficacy of the RP2D identified from Part A in KRAS G12C inhibitor naïve patients |
| avutometinib (VS-6766)+sotorasib+defactinib - KRAS G12C inhibitor exposed | EXPERIMENTAL | To determine the efficacy of the RP2D identified from Part A in KRAS G12C inhibitor exposed patients |
| Name | Type | Description |
|---|---|---|
| avutometinib (VS-6766) | DRUG | Monotherapy |
| avutometinib (VS-6766) and Defactinib | DRUG | Combination therapy |
| avutometinib (VS-6766) and adagrasib | DRUG | The RP2D of VS-6766 + adagrasib determined in Part A will be used in Part B dose expansion |
| avutometinib and sotorasib | DRUG | The RP2D of avutometinib + sotorasib determined in Part A will be used in Part B dose expansion |
| avutometinib and sotorasib and defactinib | DRUG | The RP2D of avutometinib + sotorasib + defactinib determined in Part A will be used in Part B dose expansion |
Inclusion Criteria: * Male or female subjects ≥ 18 years of age * Histologic or cytologic evidence of NSCLC * Known KRAS or BRAF mutation * The subject must have received appropriate prior therapy * Measurable disease according to RECIST 1.1 * An Eastern Cooperative Group (ECOG) performance status ...