Recruiting
Phase 2

VS-7375 & Cetuximab

Sponsor:

Verastem, Inc.

Code:

NCT07644559

Conditions

Pancreatic Ductal Adenocarcinoma (PDAC)

G12D Mutated KRAS

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

VS-7375

cetuximab

Study Details

Brief 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

Conditions

Pancreatic Ductal Adenocarcinoma (PDAC)

G12D Mutated KRAS

Study ID

NCT07644559

Start date

Jun 16, 2026

Status verified date

Aug, 2026

Completion date

Dec, 2028

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

180 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: VS-7375 Monotherapy

experimental: VS-7375 + cetuximab 2L PDAC

experimental: VS-7375 + cetuximab 1L PDAC

Interventions

VS-7375

Taken by mouth

cetuximab

Subcutaneous infusion

Primary outcome measure

  • Confirmed ORR by blinded independent central review (BICR) per RESIST v1.1 [ Time Frame: 6 months ]
  • 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. [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Verastem Call Center

7812924204VS-7375-201TrialSupport@verastem.com

Luke Chung, MD

VS-7375-201Medical@verastem.com

Locations

START- Los Angeles

Recruiting

Los Angeles, California, United States, 90025

Contacts

Hope Team

hopeteam@startresearch.com

Principal Investigator:

Navid Hafez, MD

Cedars-Sinai Medical Center

Recruiting

Los Angeles, California, United States, 90048

Contacts

Zachariah Brown

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

Principal Investigator:

Arsen Osipov, MD

Valkyrie Clinical Trials

Recruiting

Los Angeles, California, United States, 90067

Contacts

Trenis Palmer

4245351874trenis.palmer@vctcare.com

Principal Investigator:

David Berz, MD

Mayo Clinical Florida

Recruiting

Jacksonville, Florida, United States, 32224

Contacts

Clinical Trials Referral Office

855-776-0015

Principal Investigator:

Umair Majeed, MD

Moffitt Cancer Center

Recruiting

Tampa, Florida, United States, 33612

Contacts

Brianna Holder

Brianna.Holder@moffitt.org

Principal Investigator:

Dae-Won Kim, MD

Johns Hopkins University

Recruiting

Baltimore, Maryland, United States, 21287

Contacts

Colleen Apostol

apostco@jhmi.edu

Principal Investigator:

Mari Nakazawa, MD

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Harshabad Singh, MD

617-724-4000sharshabad@mgb.org

Principal Investigator:

Harshabad Singh, MD

Dana-Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Danielle Lindquist

857-215-2351DanielleA_Lindquist@DFCI.HARVARD.EDU

Principal Investigator:

Kimberly Perez, MD

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Cancer Answer Line

1-800-865-1125CancerAnswerLine@med.umich.edu

Principal Investigator:

Vaibhav Sahai, MD

START Midwest

Recruiting

Grand Rapids, Michigan, United States, 49546

Contacts

Hope Team

hopeteam@startresearch.com

Principal Investigator:

Sreenivasa Chandana, MD

Mayo Clinical Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Clinical Trial Referral Office

855-776-0015

Principal Investigator:

Ryan Carr, MD

Washington University

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Olive Pressey

olive@wustl.edu

Principal Investigator:

Kian-Huat Lim, MD

START New Jersey

Recruiting

East Brunswick, New Jersey, United States, 08816

Contacts

Hope Team

hopeteam@startresearch.com

Principal Investigator:

Bruno Fang, MD

NYU-Manhattan

Recruiting

New York, New York, United States, 10016

Contacts

Monica Dureja

2122634415Monica.Dureja@nyulangone.org

Principal Investigator:

Kristen Spencer, MD

University of North Carolina

Recruiting

Chapel Hill, North Carolina, United States, 27599

Contacts

Catherine Griffin

catherine_griffin@med.unc.edu

Principal Investigator:

Ashwin Somasundaram, MD

Sarah Cannon Research Institute

Recruiting

Nashville, Tennessee, United States, 37203

Contacts

Karlie Williams

6153297274Karlie.Williams@scri.com

Principal Investigator:

Meredith Pelster, MD

START Dallas

Recruiting

Fort Worth, Texas, United States, 76104

Contacts

Hope Team

hopeteam@startresearch.com

Principal Investigator:

Salwan Almutar, MD

MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77054

Contacts

Michelle Escano-Caballero

7137941776MEscano@mdanderson.org

Principal Investigator:

Shubham Pant, MD

START- San Antonio

Recruiting

San Antonio, Texas, United States, 78229

Contacts

Hope Team

hopeteam@startresearch.com

Principal Investigator:

Drew Rasco, MD

START- Mountain Region

Recruiting

West Valley City, Utah, United States, 84119

Contacts

HOPE Team

801-907-4750hopeteam@startresearch.com

Principal Investigator:

William McKean, MD

UVA Health

Recruiting

Charlottesville, Virginia, United States, 22903

Contacts

Clinical Trials Navigator

4349820539UVACANCERTRIALS@uvahealth.org

Principal Investigator:

Matthew Reilley, MD

Virginia Cancer Specialists

Recruiting

Fairfax, Virginia, United States, 22031

Contacts

Melissa Hackmaster

melissa.hackmaster@usoncology.com

Principal Investigator:

Alexander Spira, MD

Virginia Mason

Recruiting

Seattle, Washington, United States, 98101

Contacts

Kara Turner

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

Principal Investigator:

Vincent Picozzi, MD

UW Health

Recruiting

Madison, Wisconsin, United States, 53792

Contacts

Cancer Connect

8006228922cancerconnect@uwhealth.org

Principal Investigator:

Noelle LoConte, MD

Sunnybrook Health Sciences Centre

Recruiting

Toronto, Ontario, Canada, M4N 3M5

Contacts

Yinmin Ou

416-480-5000yinmin.ou@sunnybrook.ca

Roshni Ravindranathan

416-480-5000roshni.ravindranathan@sunnybrook.ca

Principal Investigator:

Michael Raphael, MD

Princess Margaret Cancer Center

Recruiting

Toronto, Ontario, Canada, M5G 2M9

Contacts

Morteza Azhdarzadeh

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

Principal Investigator:

Jennifer Knox, MD

More Information

Sponsor

Verastem, Inc.

Last update posted

Sep 3, 2026

Last verified

Aug, 2026

Keywords

  • KRAS G12D mutation
  • KRAS
  • PDAC
  • Pancreatic Ductal Adenocarcinoma
  • Pancreatic Cancer
  • Pancreatic Neoplasms
  • RAS

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Verastem, Inc. on 2026-09-03.