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

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

Interventions

• VS-7375 · DRUG

  Taken by mouth

• cetuximab · DRUG

  Subcutaneous infusion

Published eligibility criteria

Verbatim from the registry. Only the site can decide how these apply to a specific patient.

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

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

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

Sites (28)

• START- Los Angeles, Los Angeles, California · RECRUITING
• Cedars-Sinai Medical Center, Los Angeles, California · RECRUITING
• Valkyrie Clinical Trials, Los Angeles, California · RECRUITING
• Mayo Clinical Florida, Jacksonville, Florida · RECRUITING
• Moffitt Cancer Center, Tampa, Florida · RECRUITING
• Johns Hopkins University, Baltimore, Maryland · RECRUITING
• Massachusetts General Hospital, Boston, Massachusetts · RECRUITING
• Dana-Farber Cancer Institute, Boston, Massachusetts · RECRUITING
• University of Michigan, Ann Arbor, Michigan · RECRUITING
• START Midwest, Grand Rapids, Michigan · RECRUITING
• Mayo Clinical Rochester, Rochester, Minnesota · RECRUITING
• Washington University, St Louis, Missouri · RECRUITING
• START New Jersey, East Brunswick, New Jersey · RECRUITING
• NYU-Manhattan, New York, New York · RECRUITING
• University of North Carolina, Chapel Hill, North Carolina · RECRUITING
• Sarah Cannon Research Institute, Nashville, Tennessee · RECRUITING
• START Dallas, Fort Worth, Texas · RECRUITING
• MD Anderson Cancer Center, Houston, Texas · RECRUITING
• START- San Antonio, San Antonio, Texas · RECRUITING
• START- Mountain Region, West Valley City, Utah · RECRUITING
• UVA Health, Charlottesville, Virginia · RECRUITING
• Virginia Cancer Specialists, Fairfax, Virginia · RECRUITING
• Virginia Mason, Seattle, Washington · RECRUITING
• UW Health, Madison, Wisconsin · RECRUITING
• Macquarie University Hospital, Sydney, New South Wales, Australia · RECRUITING
• ICON Kurralta Park, Kurralta Park, South Australia, Australia · RECRUITING
• ICON Cancer Centre, South Brisbane, Australia · RECRUITING
• Princess Margaret Cancer Center, Toronto, Ontario, Canada · RECRUITING