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Colorectal CancerPhase 2TARGET-D 203NCT07659795

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

A Phase 2 study testing VS-7375, cetuximab and panitumumab in people with Colorectal Cancer, run by Verastem, Inc. at 30 sites in 2 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 or panitumumab and cetuximab plus mFOLFOX in patients with metastatic KRAS G12D - mutated Colorectal Cancer Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colorectal Cancer
What is being tested?
VS-7375, cetuximab and panitumumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
30 sitesin 2 countries
Study dates
28 Jul 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

  • 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
Show all 10Show fewer
  • 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.

Who cannot join

  • 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
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 or H2 blocker within 5 days
  • Inability to swallow oral medication
  • Other protocol-defined inclusion/exclusion criteria may apply

Trial locations and contacts

30 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Verastem Call Center contact

7812924204

VS-7375-203TrialSupport@verastem.com

Bina Tejura, MD contact

VS-7375-203Medical@verastem.com

30 sites in 2 countries

United States23 sites, 23 recruiting

  • University of North Carolina

    Chapel Hill, North Carolina, 27514

    Catherine Griffin, 919-966-4432, catherine_griffin@med.unc.edu

    Michael Iglesia, MD, PhD

    Recruiting

  • UVA Comprehensive Cancer Center

    Charlottesville, Virginia, 22908

    Clinical Trials Navigator, 434-982-0539, UVACANCERTRIALS@uvahealth.org

    Matthew Reilley, MD

    Recruiting

  • Case Western, University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106

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

    Amit Mahipal, MD

    Recruiting

  • BRCR - Coral Springs

    Coral Springs, Florida, 33065

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

    Sumit Sawhney, MD

    Recruiting

  • START New Jersey

    East Brunswick, New Jersey, 08816

    START Hope Team, 732-426-4750, hopeteam@startresearch.com

    Bruno S Fang, M.D.

    Recruiting

  • Virginia Cancer Specialists

    Fairfax, Virginia, 22031

    VCS Research Referrals, 703-636-1473, vcsresearchreferrals@usoncology.com

    Recruiting

  • START Dallas Fort Worth

    Fort Worth, Texas, 76104

    START Hope Team, 682-350-3010, hopeteam@startresearch.com

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

    Recruiting

  • START Midwest

    Grand Rapids, Michigan, 49546

    START Hope Team, 616-954-5554, hopeteam@startresearch.com

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

    Recruiting

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

    MD Anderson Cancer Center, GI Medical Oncology Dept, 855-982-0789, GIClinicalTrials@mdanderson.org

    Christine Parseghian, MD

    Recruiting

  • Indiana University, Simon Comprehensive Cancer Center

    Indianapolis, Indiana, 46202

    Yvonne LaFary, 317-278-5613, ylafary@iu.edu

    Anita Turk, M.D.

    Recruiting

  • START Los Angeles

    Los Angeles, California, 90025

    START Hope Team, 424-465-1820, hopeteam@startresearch.com

    Navid Hafez, M.D., MPH

    Recruiting

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

    Cedars-Sinai Trial Information, 1-800-233-2771, GroupCancerTrialInformation@cshs.org

    Jun Gong, MD

    Recruiting

  • Valkyrie Clinical Trials (contact for more locations)

    Los Angeles, California, 90067

    Trenis Palmer, PhD, 912-398-3205, trenis.palmer@vctcare.com

    David Berz, MD, PhD, MPH

    Recruiting

  • University of Wisconsin

    Madison, Wisconsin, 53792

    UW Cancer Connect, 800-622-8922, cancerconnect@uwhealth.org

    Dustin Deming, MD

    Recruiting

  • Sarah Cannon Research Institute Oncology Partners

    Nashville, Tennessee, 37203

    ASK SARAH, 877-691-7274, askSARAH@scresearch.net

    Meredith Pelster, MD

    Recruiting

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

    New York, New York, 10016

    Rafael Winograd, MD, PhD, 646-501-7802, CancerTrials@nyulangone.org

    Rafael Winograd, MD, PhD

    Recruiting

  • Huntsman Cancer Institute - University of Utah

    Salt Lake City, Utah, 84112

    Susan Sharry, 801-585-3453, susan.sharry@hci.utah.edu

    Christopher Nevala-Plagemann, MD

    Recruiting

  • HonorHealth

    Scottsdale, Arizona, 85258

    Sunil Sharma, MD, 480-323-1350, ssharma@honorhealth.com

    Sunil Sharma, MD

    Recruiting

  • Virginia Mason Medical Center

    Seattle, Washington, 98101

    Cancer Research Team, 206-287-6270, crp@benaroyaresearch.org

    Jessica Lee, DO

    Recruiting

  • Washington University

    St Louis, Missouri, 63110

    Caroline Bumb, 314-747-4000, cbumb@wustl.edu

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

    Recruiting

  • BRCR - Tamarac

    Tamarac, Florida, 33321

    Diana Casas, 561-447-0614, dianac@brcrglobal.com

    Andrew Schneider, MD

    Recruiting

  • Moffitt Cancer Center

    Tampa, Florida, 33612

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

    Tiago Biachi de Castria, MD, PhD

    Recruiting

  • START Mountain Region

    West Valley City, Utah, 84119

    START Hope Team, 801-907-4750, hopeteam@startresearch.com

    José M Pacheco, M.D.

    Recruiting

Other trials in United States

Australia7 sites, 7 recruiting

  • Icon Cancer Centre Hobart

    Hobart, Tasmania, 7000

    Icon Cancer Centre Hobart, 03 6240 2600, hobart.research@icon.team

    Louise Nott, BMedSci, MBBS(Hons), FRACP

    Recruiting

  • Icon Cancer Centre Townsville

    Hyde Park, Queensland, 4812

    Peyman Halvaeikhanekahdani, 61747957100, peyman.halvaeikhanekahdani@icon.team

    Abhishek Joshi, MBBS, MD, DM, FRACP

    Recruiting

  • Icon Cancer Centre Adelaide

    Kurralta Park, South Australia, 5037

    Icon Cancer Centre Adelaide/Kurralta Park, 08 8474 0220, EthicsCoordinator@icon.team

    Carolyn Bampton, MBBS, FRACP

    Recruiting

  • Macquarie University Hospital

    Macquarie Park, New South Wales, 2109

    Sam Ly, +612 9812 3538, sam.ly@mq.edu.au

    Jignasa Mahida, +61 466 476 498, Jignasa.mahida@mq.edu.au

    Recruiting

  • Alfred Hospital

    Melbourne, Victoria, 3004

    Ben Markman, MBBS (Hons), FRACP, 390763129, ben.markman@monash.edu

    Kate Sinn, 390760569, K.Sinn@alfred.org.au

    Recruiting

  • Icon Cancer Centre South Brisbane

    South Brisbane, Queensland, 4101

    Apryl Chelin, 07 3737 4700, Apryl.chelin@icon.team

    Jermaine Coward, MBBS, MRCP (UK), FRACP, PhD

    Recruiting

  • Calvary Mater Newcastle

    Waratah, New South Wales, 2298

    Emily Munn, 02 4014 3290, emily.munn@health.nsw.gov.au

    Girish Mallesara, MBBS, MD, DM, FRACP

    Recruiting

Other trials in Australia

About this study

Official title: A Phase 2, Open-label Study of VS-7375, an Oral KRAS G12D (ON/OFF) Inhibitor, With and Without an Anti-EGFR Antibody, and With an Anti-EGFR Antibody and Chemotherapy, in Patients With Metastatic KRAS G12D-Mutated Colorectal Adenocarcinoma (TARGET-D 203)

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

Being tested
VS-7375, cetuximab, panitumumab, Cetuximab + mFOLFOX6
Medical subject headings
Colorectal 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

  • cetuximabDrug

    Intravenous infusion

  • panitumumabDrug

    Intravenous infusion

  • Cetuximab + mFOLFOX6Drug

    Intravenous infusion

Study groups in NCT07659795
Study groupRoleWhat they receive
VS-7375 Monotherapy or Preferred Combination in 2L+ CRCExperimentalParticipants randomized to a treatment in 2:1 ratio
Receives: Drug: VS-7375; Drug: cetuximab; Drug: panitumumab
VS-7375 with chosen regimen in 2L+ CRCExperimentalNot described
Receives: Drug: VS-7375; Drug: cetuximab; Drug: panitumumab
VS-7375 + cetuximab and mFOLFOX in 1L CRCExperimentalNot described
Receives: Drug: Cetuximab + mFOLFOX6

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 - 2L CRC only

    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 or panitumumab, administered on a daily oral schedule in participants with KRAS G12D-mutated 2L+ CRC

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

    Measured: 6 months

  3. 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

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

    Measured: 6 months

Secondary outcomes (6)

  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 or panitumumab or cetuximab + mFOLFOX, administered on a daily oral schedule in participants with KRAS G12D-mutated CRC

    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 colorectal cancer patients

    Measured: 24 months

  6. Time to next therapy

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

    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 posted22 Jun 2026
  2. Study start28 Jul 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
Crossover
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07659795
Sponsor's protocol ID
VS-7375-203
Other IDs
2026-526473-42-00
Acronym
TARGET-D 203
Status last verified
Jul 2026
First submitted
15 Jun 2026
Last updated
26 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing VS-7375, cetuximab and panitumumab in people with Colorectal Cancer, run by Verastem, Inc. at 30 sites in 2 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 10 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 26 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 30 sites in United States, Australia. 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-7375-203TrialSupport@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 - 2L CRC only (time frame: 6 months). The study lists 3 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 NCT07659795.

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 26 Oct 2026.

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