NCT07644559

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
Verastem, Inc.
~180 participants
Updated 2026-09-03 on ClinicalTrials.gov
What's tested:VS-7375cetuximab

At a glance

Recruiting sites
29 of 29 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Confirmed ORR by blinded independent central review (BICR) per RESIST v1.1
Measured over 6 months
+1 more outcome measured
Pancreatic Ductal Adenocarcinoma (PDAC)
G12D Mutated KRAS

NCT07644559

Where you'd take part

This study runs at 29 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Cedars-Sinai Medical Center

    Los Angeles, Californiastudy coordinator listed

    Recruiting

  • Dana-Farber Cancer Institute

    Boston, Massachusettsstudy coordinator listed

    Recruiting

  • ICON Cancer Centre

    South Brisbane, Australiastudy coordinator listed

    Recruiting

  • ICON Kurralta Park

    Kurralta Park, South Australia, Australiastudy coordinator listed

    Recruiting

  • Johns Hopkins University

    Baltimore, Marylandstudy coordinator listed

    Recruiting

  • Macquarie University Hospital

    Sydney, New South Wales, Australiastudy coordinator listed

    Recruiting

  • Massachusetts General Hospital

    Boston, Massachusettsstudy coordinator listed

    Recruiting

  • Mayo Clinical Florida

    Jacksonville, Floridastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Opens a ready-to-send draft in your own email app — review before sending.

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Eligibility criteria

Inclusion

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
Received only 1 prior Tx in the metastatic setting; prior adjuvant counts as a line if progressed within 6 months
Treatment-naïve or received ≤ 1 cycle of SoC for metastatic disease

Exclusion

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
  • Confirmed ORR by blinded independent central review (BICR) per RESIST v1.16 months

    Overall Response Rate per RECIST version 1.1, per blinded independent central review (BICR)

  • 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.6 months

    Proportion/number of participants with AEs, TEAEs, TRAEs, SAEs, and dose interruptions/reductions and discontinuations.