Clinical Trial 24243

• Overview

  Study Title:

  A Phase 2, Open-label Study of VS-7375, an Oral KRAS G12D (ON/OFF) Inhibitor, as Monotherapy and with Cetuximab, in Patients with Metastatic KRAS G12D-Mutated Pancreatic Cancer (TARGET-D 201)

  Summary:

  This study will assess the safety and efficacy of VS-7375 alone and in combination with cetuximab in patients with metastatic KRAS G12D - mutated Pancreatic Cancer.

  Objective:

  Primary Objectives: * To evaluate the anti-tumor efficacy of 900 mg VS-7375 monotherapy or 900 mg VS-7375 in combination with cetuximab, administered on a daily oral schedule in participants with metastatic KRAS G12D-mutated PDAC. * To characterize the safety and tolerability of VS-7375 monotherapy or in combination with cetuximab, administered on a daily oral schedule in participants with KRAS G12D-mutated PDAC. Secondary Objectives: * To evaluate additional efficacy parameters of VS-7375 monotherapy and VS-7375 in combination with cetuximab, administered on a daily oral schedule in participants with KRAS G12D-mutated PDAC. * To continue to evaluate the PK of VS-7375 in participants with KRAS G12D-mutated PDAC.

• Treatments

  Therapies:

  KRAS G12D Mutation Inhibitor; Monoclonal antibody

  Medications:

  Cetuximab (); Erbitux (Cetuximab); VS-7375 ()

• Inclusion Criteria

  Key Inclusion Criteria:
  • Histopathology 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.
  • Additional criteria may apply.

• Exclusion Criteria

  Key Exclusion criteria:
  • Have any other documented co-existing common RAS mutation(s).
  • 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.
  • History of drug-induced Interstitial Lung Disease.
  • Receipt of prior direct RAS inhibitor.
  • Untreated or symptomatic CNS metastasis.
  • 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.
  • Receipt of PPI or H2 blocker within 5 days.
  • Inability to swallow oral medication.
  • Other protocol-defined inclusion/exclusion criteria may apply.
  • Additional criteria may apply.

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