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.
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
- Conditions the study is for
- Pancreatic Ductal Adenocarcinoma (PDAC), G12D Mutated KRAS
- What is being tested?
- VS-7375 and cetuximab (or panitumumab if α-gal IgE+ or cetuximab reaction)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- 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
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) :
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- -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
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- 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.
Luke Chung, MD contact
38 sites in 4 countries
United States27 sites, 27 recruiting
- 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
Australia7 sites, 7 recruiting
- 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
Canada2 sites, 2 recruiting
- 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
Puerto Rico2 sites, 2 recruiting
- 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
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 group | Role | What they receive |
|---|---|---|
| VS-7375 Monotherapy | Experimental | Not described Receives: Drug: VS-7375 |
| VS-7375 + cetuximab 2L PDAC | Experimental | Not described Receives: Drug: VS-7375; Drug: cetuximab (or panitumumab if α-gal IgE+ or cetuximab reaction) |
| VS-7375 + cetuximab 1L PDAC | Experimental | Not 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.
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
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)
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
Plasma Pharmacokinetics (PK) of VS-7375 and relevant metabolites, Cmax
Maximum concentration (Cmax)
Measured: 20 weeks
Plasma Pharmacokinetics (PK) of VS-7375 and relevant metabolites, AUC
Area under plasma Concentration (AUC) 0 to t
Measured: 20 weeks
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
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
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
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.
- First posted12 Jun 2026
- Study start16 Jun 2026
- Primary completionJun 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic Ductal Adenocarcinoma (PDAC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Verastem, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
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