Study of Avutometinib (VS-6766) + Adagrasib in KRAS G12C NSCLC Patients
Part of paid clinical trials in San Francisco, California.
- Sponsor
- Verastem, Inc.
- Study ID
- NCT05375994
- Phase
- PHASE1/PHASE2
- Status
- Active Not Recruiting
Conditions
- Advanced Cancer
- KRAS Activating Mutation
- Malignant Neoplasm of Lung
- Malignant Neoplastic Disease
- Metastatic Cancer
- Non Small Cell Lung Cancer
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- avutometinib (VS-6766) and adagrasib — DRUGThe RP2D of VS-6766 + adagrasib determined in Part A will be used in Part B dose expansion
Study Details
This study will assess the safety and efficacy of avutometinib (VS-6766) in combination with adagrasib in patients with G12C Non-Small Cell Lung Cancer (NSCLC) who have been exposed to prior G12C inhibitor and experienced progressive disease.
Key Dates
- Start date
- Aug 1, 2022
- Status verified
- May 2025
- Primary completion
- Dec 24, 2025
- Completion
- Jan 1, 2026
Study Design
- Enrollment
- 85 participants (estimated)
- Allocation
- NON_RANDOMIZED
- Intervention model
- SEQUENTIAL
- Primary purpose
- TREATMENT
Arms
- Experimental: avutometinib(VS-6766)+adagrasibTo determine the recommended phase 2 dose (RP2D) for VS-6766 in combination with adagrasib in G12C inhibitor exposed patients
- Experimental: avutometinib (VS-6766)+adagrasib RP2DTo determine the efficacy of the RP2D identified from Part A in G12C inhibitor exposed patients
Primary Outcome Measure
Part A: To determine RP2D for avutometinib(VS-6766) in combination with adagrasib [ Time Frame: From start of treatment to confirmation of RP2D; 28 days ]
Locations (8)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| UCSF Thoracic Oncology | San Francisco | California | 94158 | - |
| University of Colorado Hospital Anschutz Cancer Pavllion | Aurora | Colorado | 80045 | - |
| Mayo Clinic Cancer Center | Jacksonville | Florida | 32224 | - |
| Mayo Clinic Cancer Center | Rochester | Minnesota | 55905 | - |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | - |
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 275514 | - |
| Virginia Cancer Specialists, NEXT Oncology | Fairfax | Virginia | 22031 | - |
| Medical College Wisconsin | Milwaukee | Wisconsin | 53226 | - |
Find similar trials in San Francisco, CA
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UCSF Thoracic Oncology· San Francisco, CAUniversity of Colorado Hospital Anschutz Cancer Pavllion· Aurora, COMayo Clinic Cancer Center· Jacksonville, FLMayo Clinic Cancer Center· Rochester, MNMemorial Sloan Kettering Cancer Center· New York, NYUniversity of North Carolina at Chapel Hill· Chapel Hill, NC
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