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
You may not be if
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.
Clareo Health | A Phase 1/2 Study of VS-7375 in Patients With KRAS G12D-Mutated Solid Tumors