A Phase 2 Study of VS-7375 in Patients With KRAS G12D-Mutated Pancreatic Cancer
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)
1 other identifier
interventional
180
2 countries
20
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jun 2026
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 26, 2026
CompletedFirst Posted
Study publicly available on registry
June 12, 2026
CompletedStudy Start
First participant enrolled
June 16, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2028
July 29, 2026
July 1, 2026
12 months
May 26, 2026
July 27, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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)
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.
6 months
Secondary Outcomes (6)
Confirmed ORR per RECIST v1.1 assessed by BICR (primary) and Investigator (secondary) assessments.
24 months
Plasma Pharmacokinetics (PK) of VS-7375 and relevant metabolites, Cmax
20 weeks
Plasma Pharmacokinetics (PK) of VS-7375 and relevant metabolites, AUC
20 weeks
To evaluate Pharmacodynamics (PD) and other relevant blood tumor markers specific to tumor type
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)
24 months
- +1 more secondary outcomes
Other Outcomes (1)
Imaging of tumor metabolism changes
24 months
Study Arms (3)
VS-7375 Monotherapy
EXPERIMENTALVS-7375 + cetuximab 2L PDAC
EXPERIMENTALVS-7375 + cetuximab 1L PDAC
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Verastem, Inc.lead
Study Sites (20)
START- Los Angeles
Los Angeles, California, 90025, United States
Valkyrie Clinical Trials
Los Angeles, California, 90067, United States
Moffitt Cancer Center
Tampa, Florida, 33612, United States
Johns Hopkins University
Baltimore, Maryland, 21287, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215, United States
START Midwest
Grand Rapids, Michigan, 49546, United States
Washington University
St Louis, Missouri, 63110, United States
START New Jersey
East Brunswick, New Jersey, 08816, United States
NYU-Manhattan
New York, New York, 10016, United States
University of North Carolina
Chapel Hill, North Carolina, 27599, United States
Sarah Cannon Research Institute
Nashville, Tennessee, 37203, United States
START Dallas
Fort Worth, Texas, 76104, United States
MD Anderson Cancer Center
Houston, Texas, 77054, United States
START- San Antonio
San Antonio, Texas, 78229, United States
START- Mountain Region
West Valley City, Utah, 84119, United States
UVA Health
Charlottesville, Virginia, 22903, United States
Virginia Cancer Specialists
Fairfax, Virginia, 22031, United States
UW Health
Madison, Wisconsin, 53792, United States
ICON Kurralta Park
Kurralta Park, South Australia, 5037, Australia
ICON Cancer Centre
South Brisbane, QLD 4101, Australia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 26, 2026
First Posted
June 12, 2026
Study Start
June 16, 2026
Primary Completion (Estimated)
June 1, 2027
Study Completion (Estimated)
December 1, 2028
Last Updated
July 29, 2026
Record last verified: 2026-07