Clinical Trial 24402

• Overview

  Study Title:

  A Phase 2, Open-label Study of VS-7375, an Oral KRAS G12D (ON/OFF) Inhibitor, in Patients with Previously Treated, Advanced KRAS G12D-Mutated Non-Small Cell Lung Cancer (TARGET-D 202)

  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 Non-Small Cell Lung Cancer.

  Objective:

  Primary Objective(s): *To evaluate the anti-tumor efficacy of VS-7375 administered on a daily oral schedule in participants with unresectable locally advanced or metastatic KRAS G12D-mutated NSCLC who have received at least 1 and no more than 2 prior lines of systemic therapy or who have asymptomatic and untreated brain metastases and have had at least 1 and no more than 3 prior lines of systemic therapy. *To characterize the safety and tolerability of VS-7375 administered on a daily oral schedule in participants with unresectable locally advanced or metastatic KRAS G12D-mutated NSCLC who have received at least 1 and no more than 2 prior lines of systemic therapy or who have asymptomatic and untreated brain metastases and have had at least 1 and no more than 3 prior lines of systemic therapy. Secondary Objective(s): *To evaluate additional efficacy parameters of VS-7375 administered on a daily oral schedule in participants with unresectable locally advanced or metastatic KRAS G12D-mutated NSCLC. *To continue to evaluate the PK of VS-7375 in participants with unresectable locally advanced or metastatic KRAS G12D-mutated NSCLC.

• Treatments

  Therapies:

  Potent, selective, non-covalent, orally bioavailable small-molecule inhibitor

  Medications:

  VS-7375 ()

• Inclusion Criteria

  Inclusion Criteria:
  • Histopathology confirmed unresectable locally advanced or metastatic NSCLC.
  • 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.
  • Received prior treatment with a platinum-based chemotherapy regimen and an immune checkpoint inhibitor in the advanced, non-resectable setting.
  • Have documented disease progression during or following their most recent prior line of therapy.

• Exclusion Criteria

  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.
  • 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.

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