Tests VS-7375 in adults with advanced solid tumors carrying a KRAS G12D mutation
Tests the drug VS-7375, alone or combined, in adults with advanced KRAS G12D-mutated cancers.
Plain-language title generated from the registry record
Registry title: A Phase 1/2 Study of VS-7375 in Patients With KRAS G12D-Mutated Solid Tumors
Key facts
- Where
- Lyon, Marseille, and Paris, FranceSee the 3 sites
- Phase
- Phase 1/2
Where in France
- Centre Leon BerardLyon, FranceTaking people
- Centre d'Essais Precoces en Cancerologie de Marseille (CEPCM)Marseille, FranceTaking people
- Institut CurieParis, FranceTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Verastem, Inc.
- Trial code
- NCT07020221
- Record updated
- 10 November 2026
- Original description
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.Read full original descriptionShow less
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-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.
Inclusion: 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.
Exclusion: 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; 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; Symptomatic, untreated, or actively progressing known central nervous system (CNS) metastases; Individuals who are pregnant or breastfeeding.