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Taking people in United StatesPhase 2

Tests VS-7375 alone and with cetuximab in KRAS G12D pancreatic cancer

Tests the oral drug VS-7375, alone or with cetuximab, in adults with metastatic pancreatic cancer.

Key facts

Who runs it
Verastem, Inc.
Where
Ann Arbor, Baltimore, Boston, Chapel Hill, Charlottesville, Chicago, Coral Springs, East Brunswick, Fairfax, Fort Worth, Grand Rapids, Houston, Jacksonville, Los Angeles, Madison, Nashville, New York, Rochester, San Antonio, Seattle, St Louis, Tamarac, Tampa, and West Valley City, United StatesSee the 27 sitesAlso in 3 other countries, 11 sites
Trial code
Registry title
A Phase 2 Study of VS-7375 in Patients With KRAS G12D-Mutated Pancreatic Cancer
Status
Recruiting
Phase
Phase 2
People taking part
185 people, planned
Started
16 Jun 2026
Expected to end
Dec 2028
Type of study
Interventional, 3 groups
Treatments tested
  • VS-7375
  • cetuximab (or panitumumab if α-gal IgE+ or cetuximab reaction)
Record updated
13 November 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with pancreatic cancer that has spread and carries a KRAS G12D change. It tests VS-7375 alone and with cetuximab.

Age
18 years or older
Sex
Men and women
Disease stage
Pancreatic ductal adenocarcinoma that has spread (metastatic), confirmed by tissue or cell tests, with disease that can be measured on scans (RECIST 1.1). ECOG PS 0 or 1.
Earlier treatment
For the second-line cetuximab group: only 1 earlier treatment for spread disease; earlier adjuvant treatment counts as a line if the cancer got worse within 6 months. For the first-line cetuximab group: no earlier treatment or at most 1 cycle of standard care for spread disease.
Biomarker or test result
A KRAS G12D mutation confirmed by local testing. Tissue is needed for a confirming central test.

Main reasons for not taking part

  • Another known harmful RAS mutation in KRAS
  • Earlier treatment with a direct RAS inhibitor
  • Untreated or symptomatic cancer spread to the brain or spinal cord (CNS)
  • History of drug-induced Interstitial Lung Disease
  • Cannot swallow oral medication

The registry criteria, word for word

Show all 15 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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
  • Receipt of prior direct RAS inhibitor
  • 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
  • Inability to swallow oral medication
  • History of drug-induced Interstitial Lung Disease
  • Have any documented co-existing pathogenic or likely pathogenic RAS mutation(s) in KRAS
  • Untreated or symptomatic CNS metastasis
  • Receipt of PPI, P-CABs, or H2 blocker within 5 days
  • Other protocol-defined inclusion/exclusion criteria may apply

Where in United States

Also in 3 other countries, 11 sites

  • University of MichiganAnn Arbor, United StatesContact: Cancer Answer LineTaking people
  • Johns Hopkins UniversityBaltimore, United StatesContact: Colleen ApostolTaking people
  • Dana-Farber Cancer InstituteBoston, United StatesContact: Danielle LindquistTaking people
  • Massachusetts General HospitalBoston, United StatesContact: Harshabad Singh, MDTaking people
  • University of North CarolinaChapel Hill, United StatesContact: Catherine GriffinTaking people
  • UVA HealthCharlottesville, United StatesContact: Clinical Trials NavigatorTaking people
  • University of ChicagoChicago, United StatesContact: Cancer Clinical Trials MailboxTaking people
  • BRCR Global - Coral SpringsCoral Springs, United StatesContact: Sumit SawhneyTaking people
  • START - New JerseyEast Brunswick, United StatesContact: Hope TeamTaking people
  • Virginia Cancer SpecialistsFairfax, United StatesContact: Melissa HackmasterTaking people
  • START DallasFort Worth, United StatesContact: Hope TeamTaking people
  • START | MidwestGrand Rapids, United StatesContact: Hope TeamTaking people
  • MD Anderson Cancer CenterHouston, United StatesContact: Michelle Escano-CaballeroTaking people
  • Mayo Clinical FloridaJacksonville, United StatesContact: Clinical Trials Referral OfficeTaking people
  • Cedars-Sinai Medical CenterLos Angeles, United StatesContact: Zachariah BrownTaking people
  • START - Los AngelesLos Angeles, United StatesContact: Hope TeamTaking people
  • Valkyrie Clinical TrialsLos Angeles, United StatesContact: Trenis PalmerTaking people
  • UW HealthMadison, United StatesContact: Cancer ConnectTaking people
  • Sarah Cannon Research InstituteNashville, United StatesContact: Karlie WilliamsTaking people
  • NYU-ManhattanNew York, United StatesContact: Monica DurejaTaking people
  • Mayo Clinical RochesterRochester, United StatesContact: Clinical Trial Referral OfficeTaking people
  • START | San AntonioSan Antonio, United StatesContact: Hope TeamTaking people
  • Virginia MasonSeattle, United StatesContact: Kara TurnerTaking people
  • Washington UniversitySt Louis, United StatesContact: Olive PresseyTaking people
  • BRCR Global- TamaracTamarac, United StatesContact: Diana CasasTaking people
  • Moffitt Cancer CenterTampa, United StatesContact: Brianna HolderTaking people
  • START Mountain RegionWest Valley City, United StatesContact: HOPE TeamTaking people

About the trial

What the trial wants to find out

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

The 3 groups in the trial

  • VS-7375 MonotherapyTreatment being tested

    Treatment: VS-7375

  • VS-7375 + cetuximab 2L PDACTreatment being tested

    Treatment: VS-7375 and cetuximab (or panitumumab if α-gal IgE+ or cetuximab reaction)

  • VS-7375 + cetuximab 1L PDACTreatment being tested

    Treatment: VS-7375 and cetuximab (or panitumumab if α-gal IgE+ or cetuximab reaction)

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official 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)
Plain-language title
Tests VS-7375 alone and with cetuximab in KRAS G12D pancreatic cancerGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 14 November 2026.
Record updated
13 November 2026