Recruiting

Phase 2

VS-7375, Cetuximab, Panitumumab, mFOLFOXA Phase 2 Study of VS-7375 in Patients With KRAS G12D-Mutated Colorectal Cancer

Sponsor:

Verastem, Inc.

Code:

NCT07659795

Conditions

Colorectal Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

VS-7375

cetuximab

panitumumab

Cetuximab + mFOLFOX6

Study Details

Brief summary:

This study will assess the safety and efficacy of VS-7375 alone and in combination with cetuximab or panitumumab and cetuximab plus mFOLFOX in patients with metastatic KRAS G12D - mutated Colorectal Cancer

Conditions

Colorectal Cancer

Study ID

NCT07659795

Start date

Jul 28, 2026

Status verified date

Jul, 2026

Completion date

Dec, 2028

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

Histopathology confirmed metastatic CRC
Measurable disease per RECIST 1.1
Local testing confirmed KRAS G12D mutation (tissue required for confirmatory central testing)
ECOG PS=0 or 1

2L+ patients:

Must have received at least 1 standard chemotherapy for metastatic colorectal adenocarcinoma
Have documented disease progression during or following their most recent prior line of therapy
Have either stable disease, partial response (PR), or complete response (CR) by RECIST v1.1 as the best overall response (BOR) during at least 1 prior systemic therapy.

1L patients:

Treatment-naïve or received no more than 1 cycle of standard systemic therapy 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
Receipt of prior direct RAS inhibitor
Receipt of more than 1 investigational therapy
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

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: VS-7375 Monotherapy or Preferred Combination in 2L+ CRC

Participants randomized to a treatment in 2:1 ratio

experimental: VS-7375 with chosen regimen in 2L+ CRC

experimental: VS-7375 + cetuximab and mFOLFOX in 1L CRC

Interventions

VS-7375

Taken by mouth

cetuximab

Intravenous infusion

panitumumab

Intravenous infusion

Cetuximab + mFOLFOX6

Intravenous infusion

Primary outcome measure

Confirmed ORR by blinded independent central review (BICR) per RESIST v1.1 - 2L CRC only [ Time Frame: 6 months ]
To characterize the safety and tolerability of VS-7375 monotherapy or in combination with cetuximab or panitumumab, administered on a daily oral schedule in participants with KRAS G12D-mutated 2L+ CRC [ Time Frame: 6 months ]
To characterize the safety and tolerability of VS-7375 in combination with cetuximab + mFOLFOX, administered on a daily oral schedule in participants with KRAS G12D-mutated 1L CRC [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Verastem Call Center

7812924204 VS-7375-203TrialSupport@verastem.com

Bina Tejura, MD

VS-7375-203Medical@verastem.com

Locations

HonorHealth

Recruiting

Scottsdale, Arizona, United States, 85258

Contacts

Sunil Sharma, MD

480-323-1350 ssharma@honorhealth.com

Principal Investigator:

Sunil Sharma, MD

START Los Angeles

Recruiting

Los Angeles, California, United States, 90025

Contacts

START Hope Team

424-465-1820 hopeteam@startresearch.com

Principal Investigator:

Navid Hafez, M.D., MPH

Cedars-Sinai Medical Center

Recruiting

Los Angeles, California, United States, 90048

Contacts

Cedars-Sinai Trial Information

1-800-233-2771 GroupCancerTrialInformation@cshs.org

Principal Investigator:

Jun Gong, MD

Valkyrie Clinical Trials (contact for more locations)

Recruiting

Los Angeles, California, United States, 90067

Contacts

Trenis Palmer, PhD

912-398-3205 trenis.palmer@vctcare.com

Principal Investigator:

David Berz, MD, PhD, MPH

BRCR - Tamarac

Recruiting

Tamarac, Florida, United States, 33321

Contacts

Diana Casas

561-447-0614 dianac@brcrglobal.com

Principal Investigator:

Andrew Schneider, MD

Moffitt Cancer Center

Recruiting

Tampa, Florida, United States, 33612

Contacts

Cheyenne Schneider

813-745-3691 Cheyenne.Schneider@moffitt.org

Principal Investigator:

Tiago Biachi de Castria, MD, PhD

Indiana University, Simon Comprehensive Cancer Center

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

Yvonne LaFary

317-278-5613 ylafary@iu.edu

Principal Investigator:

Anita Turk, M.D.

START Midwest

Recruiting

Grand Rapids, Michigan, United States, 49546

Contacts

START Hope Team

616-954-5554 hopeteam@startresearch.com

Principal Investigator:

Sreenivasa R Chandana, M.D., Ph.D.

Washington University

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Caroline Bumb

314-747-4000 cbumb@wustl.edu

Principal Investigator:

Kian-Huat Lim, M.D., Ph.D.

START New Jersey

Recruiting

East Brunswick, New Jersey, United States, 08816

Contacts

START Hope Team

732-426-4750 hopeteam@startresearch.com

Principal Investigator:

Bruno S Fang, M.D.

Perlmutter Cancer Center at NYU Langone Health (contact for more locations)

Recruiting

New York, New York, United States, 10016

Contacts

Rafael Winograd, MD, PhD

646-501-7802 CancerTrials@nyulangone.org

Principal Investigator:

Rafael Winograd, MD, PhD

University of North Carolina

Recruiting

Chapel Hill, North Carolina, United States, 27514

Contacts

Catherine Griffin

919-966-4432 catherine_griffin@med.unc.edu

Principal Investigator:

Michael Iglesia, MD, PhD

Case Western, University Hospitals Cleveland Medical Center

Recruiting

Cleveland, Ohio, United States, 44106

Contacts

Amit Mahipal, MD

(216)844-6031 Amit.Mahipal@UHhospitals.org

Principal Investigator:

Amit Mahipal, MD

Sarah Cannon Research Institute Oncology Partners

Recruiting

Nashville, Tennessee, United States, 37203

Contacts

ASK SARAH

877-691-7274 askSARAH@scresearch.net

Principal Investigator:

Meredith Pelster, MD

START Dallas Fort Worth

Recruiting

Fort Worth, Texas, United States, 76104

Contacts

START Hope Team

682-350-3010 hopeteam@startresearch.com

Principal Investigator:

Salwan Al Mutar, M.D., M.Sc.

The University of Texas MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

MD Anderson Cancer Center, GI Medical Oncology Dept

855-982-0789 GIClinicalTrials@mdanderson.org

Principal Investigator:

Christine Parseghian, MD

Huntsman Cancer Institute - University of Utah

Recruiting

Salt Lake City, Utah, United States, 84112

Contacts

Susan Sharry

801-585-3453 susan.sharry@hci.utah.edu

Principal Investigator:

Christopher Nevala-Plagemann, MD

START Mountain Region

Recruiting

West Valley City, Utah, United States, 84119

Contacts

START Hope Team

801-907-4750 hopeteam@startresearch.com

Principal Investigator:

José M Pacheco, M.D.

UVA Comprehensive Cancer Center

Recruiting

Charlottesville, Virginia, United States, 22908

Contacts

Clinical Trials Navigator

434-982-0539 UVACANCERTRIALS@uvahealth.org

Principal Investigator:

Matthew Reilley, MD

Virginia Cancer Specialists

Recruiting

Fairfax, Virginia, United States, 22031

Contacts

VCS Research Referrals

703-636-1473 vcsresearchreferrals@usoncology.com

Virginia Mason Medical Center

Recruiting

Seattle, Washington, United States, 98101

Contacts

Cancer Research Team

206-287-6270 crp@benaroyaresearch.org

Principal Investigator:

Jessica Lee, DO

University of Wisconsin

Recruiting

Madison, Wisconsin, United States, 53792

Contacts

UW Cancer Connect

800-622-8922 cancerconnect@uwhealth.org

Principal Investigator:

Dustin Deming, MD

More Information

Sponsor

Verastem, Inc.

Last update posted

Oct 21, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-23. This information was provided to ClinicalTrials.gov by Verastem, Inc. on 2026-10-21. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.