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Pancreatic Ductal Adenocarcinoma (PDAC)Phase 2NCT07644559

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

A Phase 2 study testing VS-7375 and cetuximab (or panitumumab if α-gal IgE+ or cetuximab reaction) in people with Pancreatic Ductal Adenocarcinoma (PDAC) and G12D Mutated KRAS, run by Verastem, Inc. at 38 sites in 4 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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 Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
VS-7375 and cetuximab (or panitumumab if α-gal IgE+ or cetuximab reaction)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
185 participants
Where
38 sitesin 4 countries
Study dates
16 Jun 2026to Dec 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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) :
Show all 9Show fewer
  • -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 join

  • 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
Show all 11Show fewer
  • 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

Trial locations and contacts

38 sites in 4 countries. Contact the study team or a site near you to ask about taking part.

Verastem Call Center contact

7812924204

VS-7375-201TrialSupport@verastem.com

Luke Chung, MD contact

VS-7375-201Medical@verastem.com

38 sites in 4 countries

United States27 sites, 27 recruiting

  • University of Michigan

    Ann Arbor, Michigan, 48109

    Cancer Answer Line, 1-800-865-1125, CancerAnswerLine@med.umich.edu

    Vaibhav Sahai, MD

    Recruiting

  • Johns Hopkins University

    Baltimore, Maryland, 21287

    Colleen Apostol, apostco@jhmi.edu

    Mari Nakazawa, MD

    Recruiting

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

    Harshabad Singh, MD, 617-724-4000, sharshabad@mgb.org

    Harshabad Singh, MD

    Recruiting

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

    Danielle Lindquist, 857-215-2351, DanielleA_Lindquist@DFCI.HARVARD.EDU

    Kimberly Perez, MD

    Recruiting

  • University of North Carolina

    Chapel Hill, North Carolina, 27599

    Catherine Griffin, catherine_griffin@med.unc.edu

    Ashwin Somasundaram, MD

    Recruiting

  • UVA Health

    Charlottesville, Virginia, 22903

    Clinical Trials Navigator, 4349820539, UVACANCERTRIALS@uvahealth.org

    Matthew Reilley, MD

    Recruiting

  • University of Chicago

    Chicago, Illinois, 60637

    Cancer Clinical Trials Mailbox, cancerclinicaltrials@bsd.uchicago.edu

    Ardaman Shergill, MD

    Recruiting

  • BRCR Global- Coral Springs

    Coral Springs, Florida, 33065

    Sumit Sawhney, (561)447-0614, ssawhney.md@brcrglobal.com

    Sumit Sawhney, MD

    Recruiting

  • START New Jersey

    East Brunswick, New Jersey, 08816

    Hope Team, hopeteam@startresearch.com

    Bruno Fang, MD

    Recruiting

  • Virginia Cancer Specialists

    Fairfax, Virginia, 22031

    Melissa Hackmaster, melissa.hackmaster@usoncology.com

    Alexander Spira, MD

    Recruiting

  • START Dallas

    Fort Worth, Texas, 76104

    Hope Team, hopeteam@startresearch.com

    Salwan Almutar, MD

    Recruiting

  • START Midwest

    Grand Rapids, Michigan, 49546

    Hope Team, hopeteam@startresearch.com

    Sreenivasa Chandana, MD

    Recruiting

  • MD Anderson Cancer Center

    Houston, Texas, 77054

    Michelle Escano-Caballero, 7137941776, MEscano@mdanderson.org

    Shubham Pant, MD

    Recruiting

  • Mayo Clinical Florida

    Jacksonville, Florida, 32224

    Clinical Trials Referral Office, 855-776-0015

    Umair Majeed, MD

    Recruiting

  • START- Los Angeles

    Los Angeles, California, 90025

    Hope Team, hopeteam@startresearch.com

    Navid Hafez, MD

    Recruiting

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

    Zachariah Brown, 310-423-5618, Zachariah.Brown@cshs.org

    Arsen Osipov, MD

    Recruiting

  • Valkyrie Clinical Trials

    Los Angeles, California, 90067

    Trenis Palmer, 4245351874, trenis.palmer@vctcare.com

    David Berz, MD

    Recruiting

  • UW Health

    Madison, Wisconsin, 53792

    Cancer Connect, 8006228922, cancerconnect@uwhealth.org

    Noelle LoConte, MD

    Recruiting

  • Sarah Cannon Research Institute

    Nashville, Tennessee, 37203

    Karlie Williams, 6153297274, Karlie.Williams@scri.com

    Meredith Pelster, MD

    Recruiting

  • NYU-Manhattan

    New York, New York, 10016

    Monica Dureja, 2122634415, Monica.Dureja@nyulangone.org

    Kristen Spencer, MD

    Recruiting

  • Mayo Clinical Rochester

    Rochester, Minnesota, 55905

    Clinical Trial Referral Office, 855-776-0015

    Ryan Carr, MD

    Recruiting

  • START- San Antonio

    San Antonio, Texas, 78229

    Hope Team, hopeteam@startresearch.com

    Drew Rasco, MD

    Recruiting

  • Virginia Mason

    Seattle, Washington, 98101

    Kara Turner, 206-341-1245, Kara.Turner@commonspirit.org

    Vincent Picozzi, MD

    Recruiting

  • Washington University

    St Louis, Missouri, 63110

    Olive Pressey, olive@wustl.edu

    Kian-Huat Lim, MD

    Recruiting

  • BRCR Global- Tamarac

    Tamarac, Florida, 33321

    Diana Casas, (561) 4470614, dianac@brcrglobal.com

    Andrew Schneider, MD

    Recruiting

  • Moffitt Cancer Center

    Tampa, Florida, 33612

    Brianna Holder, Brianna.Holder@moffitt.org

    Dae-Won Kim, MD

    Recruiting

  • START- Mountain Region

    West Valley City, Utah, 84119

    HOPE Team, 801-907-4750, hopeteam@startresearch.com

    William McKean, MD

    Recruiting

Other trials in United States

Australia7 sites, 7 recruiting

  • ICON Cancer Centre- Hobart

    Hobart, Tasmania, 7000

    Louise Nott, 03 6240 2600, hobart.research@icon.team

    Louise Nott, MD

    Recruiting

  • ICON Cancer Centre Townsville

    Hyde Park, Queensland, 4812

    Peyman Halvaeikhanekahdani, +61 747 957 100, peyman.halvaeikhanekahdani@icon.team

    Abhishek Joshi, MD

    Recruiting

  • ICON Kurralta Park

    Kurralta Park, South Australia, 5037

    Sarah Gartland, 08 84740420, Sarah.gartland@icon.team

    Carolyn Bampton, MD

    Recruiting

  • Alfred Hospital

    Melbourne, Victoria, 3004

    Kate Sinn, +61 3 9076 0569, K.Sinn@alfred.org.au

    Ben Markman, MD

    Recruiting

  • ICON Cancer Centre

    South Brisbane, QLD 4101

    Apryl Chelin, Apryl.chelin@icon.team

    Jermaine Coward, MD

    Recruiting

  • Macquarie University Hospital

    Sydney, New South Wales, 2019

    Sam Ly, 61 2 9812 3538, sam.ly@mq.edu.au

    Wei Yen Chan, MD

    Recruiting

  • Calvary Mater Newcastle

    Waratah, New South Wales, 2298

    Rosella White, 02 4014 3282, Rosella.White@health.nsw.gov.au

    Girish Mallesara, MD

    Recruiting

Other trials in Australia

Canada2 sites, 2 recruiting

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N 3M5

    Yinmin Ou, 416-480-5000 ext. 67868, yinmin.ou@sunnybrook.ca

    Roshni Ravindranathan, 416-480-5000 ext. 67336, roshni.ravindranathan@sunnybrook.ca

    Recruiting

  • Princess Margaret Cancer Center

    Toronto, Ontario, M5G 2M9

    Morteza Azhdarzadeh, 416-946-4501, Morteza.Azhdarzadeh@uhn.ca

    Jennifer Knox, MD

    Recruiting

Other trials in Canada

Puerto Rico2 sites, 2 recruiting

  • BRCR Global- San Juan

    San Juan, 00907

    Edward Morales, (561) 447-0614 ext. 416, edwardm@brcrglobal.com

    Alexandra Deya, MD

    Recruiting

  • BRCR- Yauco

    Yauco, 00698

    Maitee Costa, mcostas@brcrglobal.com

    Maryknoll De La Paz, MD

    Recruiting

Other trials in Puerto Rico

About this study

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)

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

Being tested
VS-7375, cetuximab (or panitumumab if α-gal IgE+ or cetuximab reaction)
Keywords
KRAS G12D mutation, KRAS, PDAC, Pancreatic Ductal Adenocarcinoma, Pancreatic Cancer, Pancreatic Neoplasms, RAS
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VS-7375Drug

    Taken by mouth

  • cetuximab (or panitumumab if α-gal IgE+ or cetuximab reaction)Drug

    Subcutaneous infusion

Study groups in NCT07644559
Study groupRoleWhat they receive
VS-7375 MonotherapyExperimentalNot described
Receives: Drug: VS-7375
VS-7375 + cetuximab 2L PDACExperimentalNot described
Receives: Drug: VS-7375; Drug: cetuximab (or panitumumab if α-gal IgE+ or cetuximab reaction)
VS-7375 + cetuximab 1L PDACExperimentalNot described
Receives: Drug: VS-7375; Drug: cetuximab (or panitumumab if α-gal IgE+ or cetuximab reaction)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Confirmed ORR by blinded independent central review (BICR) per RESIST v1.1

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

    Measured: 6 months

  2. 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.

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

    Measured: 6 months

Secondary outcomes (7)

  1. Confirmed ORR per RECIST v1.1 assessed by BICR (primary) and Investigator (secondary) assessments.

    To evaluate additional efficacy parameters of VS-7375 monotherapy and VS-7375 in combination with cetuximab, administered on a daily oral schedule in participants with KRAS G12D-mutated PDAC.

    Measured: 24 months

  2. Plasma Pharmacokinetics (PK) of VS-7375 and relevant metabolites, Cmax

    Maximum concentration (Cmax)

    Measured: 20 weeks

  3. Plasma Pharmacokinetics (PK) of VS-7375 and relevant metabolites, AUC

    Area under plasma Concentration (AUC) 0 to t

    Measured: 20 weeks

  4. To evaluate Pharmacodynamics (PD) and other relevant blood tumor markers specific to tumor type

    CA19-9, CEA, CA-125

    Measured: Up to 2.5 years

  5. To assess the health-related quality of life and disease based on European Organization for Research and Treatment of Cancer (EORTC) Quality of life Questionnaire Core module C30 (QLQ-C30).

    The EORTC QLQ-C30 is a validated questionnaire to assess the quality of life of pancreatic ductal adenocarcinoma patients.

    Measured: 24 months

  6. To assess the health-related quality of life and disease based on European Organization for Research and Treatment of Cancer (EORTC) Quality of life Questionnaire Core module QLQ-PAN26.

    The EORTC QLQ-PAN26 assesses the health-related QoL in patients with pancreatic cancer. QLQ-PAN26 includes 26 items related to disease symptoms, treatment side-effects, and emotional issues specific to pancreatic cancer.

    Measured: 24 months

  7. Time to next therapy.

    To assess the interval between initiation of study treatment and initiation of subsequent

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jun 2026
  2. Study start16 Jun 2026
  3. Primary completionJun 2027 (estimated)
  4. Study completionDec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
185 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07644559
Sponsor's protocol ID
VS-7375-201
Status last verified
Oct 2026
First submitted
26 May 2026
Last updated
23 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing VS-7375 and cetuximab (or panitumumab if α-gal IgE+ or cetuximab reaction) in people with Pancreatic Ductal Adenocarcinoma (PDAC) and G12D Mutated KRAS, run by Verastem, Inc. at 38 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 38 sites in United States, Australia, Canada, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Verastem Call Center (7812924204, VS-7375-201TrialSupport@verastem.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Confirmed ORR by blinded independent central review (BICR) per RESIST v1.1 (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07644559.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2026.

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Clinical Trial NCT07644559 | AzTrials