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

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.

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.