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)
Status: Recruiting
Location: See all (8) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
⁃ 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
Locations
United States
California
START- Los Angeles
RECRUITING
Los Angeles
Florida
Moffitt Cancer Center
RECRUITING
Tampa
Michigan
START Midwest
RECRUITING
Grand Rapids
Missouri
Washington University
RECRUITING
St Louis
New Jersey
START New Jersey
RECRUITING
East Brunswick
Texas
START Dallas
RECRUITING
Fort Worth
START- San Antonio
RECRUITING
San Antonio
Utah
START- Mountain Region
RECRUITING
West Valley City
Contact Information
Primary
Verastem Call Center
VS-7375-201TrialSupport@verastem.com
7812924204
Backup
Luke Chung, MD
VS-7375-201Medical@verastem.com
Time Frame
Start Date: 2026-06
Estimated Completion Date: 2028-12
Participants
Target number of participants: 180
Treatments
Experimental: VS-7375 Monotherapy
Experimental: VS-7375 + cetuximab 2L PDAC
Experimental: VS-7375 + cetuximab 1L PDAC
Related Therapeutic Areas
Sponsors
Leads: Verastem, Inc.