VS-7375-101: A Phase 1/2, Open-label Study of VS-7375, a KRAS G12D (ON/OFF) Inhibitor, as Monotherapy and in Combination, in Patients with Advanced KRAS G12D-Mutant Solid Tumors
| ClinicalTrials.gov Identifier |
| NCT07020221 |
| Institution Name |
| MD Anderson Cancer Center |
| Full Institution Address |
|
Houston, TX |
| Institution Phone |
| 832-794-3672 |
| Additional Institutions |
|
Virginia Mason Medical Center, Seattle, WA, 206-287-6272 Washington University School of Medicine, St. Louis, MO, 314-273-8602 SCRI Oncology Partners, Nashville, TN, 615-341-7844 Massachusetts General Hospital, Boston, MA, 617-742-4000 Cedars-Sinai Medical Center, Los Angeles, CA Huntsman Cancer Institute, Salt Lake City, UT, 801-585-3453 University of Pennsylvania, Abramson Cancer Center, 215-360-0919 Johns Hopkins University, Baltimore, MD, 410-614-3644 Laura &Isaac Perlmutter Cancer Center at NYU Langone, New York NY University of Michigan, Ann Arbor, MI, 800-865-1125 University of Virginia, Charlottesville, VA, 434-924-9286 Virginia Cancer Specialists, Fairfax, VA, 703-636-1473 |
| Principal Investigator |
| Dr. David Hong (MD Anderson) |
| Principal Investigator Phone |
| 832-794-3672 |
| Principal Investigator Email |
| lmnguyen1@mdanderson.org |
| Additional Principal Investigators |
|
Dr. Vincent Picozzi (Virginia Mason Medical Center) Dr. Kian-Huat Lim (Washington University School of Medicine) Dr. Melissa Johnson (SCRI Oncology Partners) Dr, Leon Pappas (Massachusetts General Hospital) Dr. Arsen Osipov (Cedars-Sinai Medical Center) Dr. Matthew Gumbleton, Huntsman Cancer Institute Dr. Mark O'Hara (University of Pennsylvania) Dr. Nilofer Azad (Johns Hopkins University) Dr. Kristen Spencer (Laura & Isaac Perlmutter Cancer Center at NYU Langone) Dr. Vaibhav Sahai (University of Michigan) Dr. Matthew Reilly (University of Virginia) Dr. Alexander Spira (Virginia Cancer Specialists) |
| Study Coordinator |
| Ly Nguyen |
| Study Coordinator Phone |
| 832-794-3672 |
| Study Coordinator Email |
| lmnguyen1@mdanderson.org |
| Additional Study Coordinators |
| We would like to refer to the contacts posted on clinicaltrials.gov if possible. |
| Study Overview |
| This is an open-label study to understand the safety, tolerability, and preliminary anticancer activity of VS-7375 alone or given with other anticancer treatments and to understand how VS-7375 moves through the body, what it does to the body, and how it affects the breakdown of certain drugs. This study has multiple cohorts to explore multiple objectives. Patients will be assigned to a part and/or cohort based on their type of cancer and whether or not they have had previous treatment for their cancer. |
| Enrollment Information |
| Actively Enrolling |
| Study Start Date |
| 2025-06-06 |
| Study End Date |
| 2028-12-31 |
| Study Purpose |
| Verastem is researching a treatment for patients with advanced solid tumors that have a specific mutation (G12D) in the KRAS gene (KRAS G12D). This mutation leads to production of a KRAS protein that is always in the “on” state and leads to uncontrolled cell growth and formation of tumors. VS-7375 is an oral medication that blocks KRAS G12D. In cells and animals, VS-7375 has shown anticancer activity by blocking the signals that cancer cells with KRAS G12D mutations use to grow and survive, and it has the potential to help people with KRAS G12-mutated cancers. There is a significant unmet medical need for treating tumors with KRAS G12D mutations and the results of experiments with VS-7375 in cells and animals support further research in patients with KRAS G12D-mutated cancers. This study will test VS-7375 alone or in combination with other anticancer treatments in patients with solid tumors that have a KRAS G12D mutation to determine if it is safe and effective in treating these cancers. |
| Inclusion Criteria |
|
Key Inclusion Criteria: Individuals ≥18 years of age. Agreement to sign and date an informed consent form (ICF) approved by theInstitutional Review Board (IRB)/Independent Ethics Committee (IEC). Histologic or cytologic evidence of solid tumor harboring a KRAS G12D mutation. Measurable disease according to Response Evaluation Criteria in Solid Tumors(RECIST) v1.1. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 Adequate organ function Adequate cardiac function Recovered from all AEs due to previous therapies to Grade ≤1 or baseline Agreement to use highly effective contraception |
| Exclusion Criteria |
|
Key Exclusion Criteria: Underwent major surgical procedure as defined by the Investigator, other than for diagnosis, within 4 weeks prior to Cycle 1 Day 1 Receipt of chemotherapy, targeted therapy, or radiotherapy (excluding palliative radiation) within 4 weeks or 5 half-lives, whichever is shorter, or immunotherapy within 4 weeks prior to Cycle 1 Day 1. Treatment with any investigational drug at least 4 weeks or 5 half-lives, whichever is shorter, prior to Cycle 1 Day 1. History of treatment with direct RAS inhibitors Symptomatic, untreated, or actively progressing known central nervous system(CNS) metastases. Inability to swallow oral medications |
| Required Tests Prior to Study |
| There are required procedures and assessments to determine eligibility for the study. These may include: review/signing of the study consent form, physical exam, pregnancy test (if applicable), lab tests, vital signs, ECGs, safety labs, urinalysis. A biopsy may also be required in some cases. |
| Potential Side Effects |
| Potential side effects are described in the study’s Informed Consent Form, which is provided to all patients considering participation. For additional information about the study, please contact a participating study site. |
| Financial Assistance Available |
| Yes |