A Phase 2 Study of VS-7375 in Patients With KRAS G12D-Mutated Pancreatic Cancer

Prior treatment

• Prior anti-cancer Tx within 4 weeks or drug-specific timeline within first treatment dose, whichever shorter
• Major surgery within 4 weeks of first treatment dose
• Radiation therapy (RT) within 1 week of first treatment dose; RT to brain or lung within 2 weeks of first treatment dose
• Receipt of prior direct RAS inhibitor
• Receipt of strong CYP3A4 inhibitor/inducer or CYP3A4 sensitive substrates with narrow therapeutic index within 14 days or drug-specific timeline within first treatment dose, whichever is shorter
• Inability to swallow oral medication

Other illness

• History of drug-induced Interstitial Lung Disease

Other

• Have any documented co-existing pathogenic or likely pathogenic RAS mutation(s) in KRAS
• Untreated or symptomatic CNS metastasis
• Receipt of PPI, P-CABs, or H2 blocker within 5 days
• Other protocol-defined inclusion/exclusion criteria may apply

• Histologic or cytologic confirmed PDAC
• Measurable disease per RECIST 1.1
• Local testing confirmed KRAS G12D mutation (tissue required for confirmatory central testing)
• ECOG PS=0 or 1
  • Adequate organ function
  • VS-7375 + cetuximab (2L PDAC) :
  • -Received only 1 prior Tx in the metastatic setting; prior adjuvant counts as a line if progressed within 6 months
  • VS-7375 + cetuximab (1L PDAC) :
  • -Treatment-naïve or received ≤ 1 cycle of SoC for metastatic disease