Recruiting
Phase 2

VS-7375, Cetuximab, Panitumumab, mFOLFOX

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

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

7812924204VS-7375-203TrialSupport@verastem.com

Luke Chung, MD

VS-7375-203Medical@verastem.com

Locations

START Los Angeles

Recruiting

Los Angeles, California, United States, 90025

Contacts

START Hope Team

424-465-1820hopeteam@startresearch.com

Principal Investigator:

Navid Hafez, M.D., MPH

Valkyrie Clinical Trials (contact for more locations)

Recruiting

Los Angeles, California, United States, 90067

Contacts

Trenis Palmer, PhD

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

Principal Investigator:

David Berz, MD, PhD, MPH

Moffitt Cancer Center

Recruiting

Tampa, Florida, United States, 33612

Contacts

Cheyenne Schneider

813-745-3691Cheyenne.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

317-278-5613ylafary@iu.edu

Principal Investigator:

Anita Turk, M.D.

START Midwest

Recruiting

Grand Rapids, Michigan, United States, 49546

Contacts

START Hope Team

616-954-5554hopeteam@startresearch.com

Principal Investigator:

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

START New Jersey

Recruiting

East Brunswick, New Jersey, United States, 08816

Contacts

START Hope Team

732-426-4750hopeteam@startresearch.com

Principal Investigator:

Bruno S Fang, M.D.

Sarah Cannon Research Institute Oncology Partners

Recruiting

Nashville, Tennessee, United States, 37203

Contacts

ASK SARAH

877-691-7274askSARAH@scresearch.net

Principal Investigator:

Meredith Pelster, MD

START Dallas Fort Worth

Recruiting

Fort Worth, Texas, United States, 76104

Contacts

START Hope Team

682-350-3010hopeteam@startresearch.com

Principal Investigator:

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

START Mountain Region

Recruiting

West Valley City, Utah, United States, 84119

Contacts

START Hope Team

801-907-4750hopeteam@startresearch.com

Principal Investigator:

José M Pacheco, M.D.

UVA Comprehensive Cancer Center

Recruiting

Charlottesville, Virginia, United States, 22908

Contacts

Clinical Trials Navigator

434-982-0539UVACANCERTRIALS@uvahealth.org

Principal Investigator:

Matthew Reilley, MD

Virginia Mason Medical Center

Recruiting

Seattle, Washington, United States, 98101

Contacts

Cancer Research Team

206-287-6270crp@benaroyaresearch.org

Principal Investigator:

Jessica Lee, DO

More Information

Sponsor

Verastem, Inc.

Last update posted

Sep 2, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Verastem, Inc. on 2026-09-02.