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Phase 1Recruiting

A Phase 1/2 Study of VS-7375 in Patients With KRAS G12D-Mutated Solid Tumors

Sponsored by Verastem, Inc.

About this study

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.

Where this study is enrolling (13)

Show all 13 locations
Who can participate

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

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.

Only the research team can confirm whether you qualify. The intake questionnaire is the best way to find out.

Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.

Trial data sourced from ClinicalTrials.gov.