A Phase 1/2 Study of VS-7375 in Patients With KRAS G12D-Mutated Solid Tumors
This study will assess the safety and efficacy of VS-7375 alone and in combination in patients with advanced solid tumors harboring a KRAS G12D-mutation.
Checked against the public recordLast updated Apr 22, 2026 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1 / Phase 2
- Sponsor
- Verastem, Inc.
- Interventions being studied
- Drug: VS-7375; Drug: Cetuximab; Drug: Carboplatin + Pemetrexed + Pembrolizumab; Drug: Gemcitabine; Drug: Gemcitabine + Nab-paclitaxel
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
Key Inclusion Criteria: * Individuals ≥18 years of age. * Agreement to sign and date an informed consent form (ICF) approved by the Institutional Review Board (IRB)/Independent Ethics Committee (IEC). * Histologic or cytologic evidence of locally advanced unresectable or metastatic 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 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 and specific KRAS G12D inhibitors. * Symptomatic, untreated, or actively progressing known central nervous system (CNS) metastases. * Inability to swallow oral medications. * Evidence or history of uncontrolled, clinically significant hematological, renal, hepatic, endocrine, pulmonary, gastrointestinal, cardiovascular, psychiatric, coagulation, neurologic, dermatologic, autoimmune, or allergic disease * Individuals who are pregnant or breastfeeding.
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Cedars-Sinai Medical CenterLos Angeles, California
- Johns Hopkins UniversityBaltimore, Maryland
- Massachusetts General HospitalBoston, Massachusetts
- University of MichiganAnn Arbor, Michigan
- Washington University School of MedicineSt Louis, Missouri
- Laura & Isaac Perlmutter Cancer Center at NYU LangoneNew York, New York
- Univ of Pennsylvania, Abramson Cancer CenterPhiladelphia, Pennsylvania
- SCRI Oncology PartnersNashville, Tennessee
- MD Anderson Cancer CenterHouston, Texas
- Huntsman Cancer InstituteSalt Lake City, Utah
- University of VirginiaCharlottesville, Virginia
- Virginia Cancer SpecialistsFairfax, Virginia
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Apr 22, 2026. Always confirm current availability with the study team.