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

RecruitingPhase 2Ages 18 Years - anyAllVerastem, Inc.
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Exclusion criteria: * Have any documented co-existing pathogenic or likely pathogenic RAS mutation(s) in KRAS * 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, P-CABs, or H2 blocker within 5 days * Inability to swallow oral medication * Other protocol-defined inclusion/exclusion criteria may apply
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What it tests

  • VS-7375
  • cetuximab (or panitumumab if α-gal IgE+ or cetuximab reaction)
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Where

38 sites
START- Los Angeles
Los Angeles, United States
Cedars-Sinai Medical Center
Los Angeles, United States
Valkyrie Clinical Trials
Los Angeles, United States
BRCR Global- Coral Springs
Coral Springs, United States
Mayo Clinical Florida
Jacksonville, United States
BRCR Global- Tamarac
Tamarac, United States
Moffitt Cancer Center
Tampa, United States
University of Chicago
Chicago, United States

…and 30 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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