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.
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
Plus 6 other study approaches.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Oct 23, 2026 · Source: ClinicalTrials.gov
The study is currently accepting participants.
Interventional
Locations may change over time.
Study sponsor
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 + Nab-paclitaxel; Drug: Pembrolizumab; Drug: Defactinib; Drug: Midazolam; Drug: Repaglinide
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- Key
- 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
- 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.
- 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: Oct 23, 2026. Always confirm current availability with the study team.