A Phase 2 Study of VS-7375 in Patients With KRAS G12D-Mutated Colorectal Cancer
Part of paid clinical trials in Los Angeles, California.
- Sponsor
- Verastem, Inc.
- Study ID
- NCT07659795
- Phase
- PHASE2
- Status
- Recruiting
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- VS-7375 — DRUGTaken by mouth
- cetuximab — DRUGIntravenous infusion
- panitumumab — DRUGIntravenous infusion
- Cetuximab + mFOLFOX6 — DRUGIntravenous infusion
Study Details
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
Key Dates
- First listed
- Jun 22, 2026
- Start date
- Jul 28, 2026
- Status verified
- Jul 2026
- Primary completion
- Jun 30, 2027
- Completion
- Dec 31, 2028
Study Design
- Enrollment
- 150 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- CROSSOVER
- Primary purpose
- TREATMENT
Arms
- Experimental: VS-7375 Monotherapy or Preferred Combination in 2L+ CRCParticipants 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
Primary Outcome Measure
Confirmed ORR by blinded independent central review (BICR) per RESIST v1.1 - 2L CRC only [ Time Frame: 6 months ]
Central Contacts
- Verastem Call Center7812924204
- Luke Chung, MD
Locations (14)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| START Los Angeles | Los Angeles | California | 90025 | Navid Hafez, M.D., MPH (PRINCIPAL_INVESTIGATOR) |
| Valkyrie Clinical Trials (contact for more locations) | Los Angeles | California | 90067 | David Berz, MD, PhD, MPH (PRINCIPAL_INVESTIGATOR) |
| Moffitt Cancer Center | Tampa | Florida | 33612 | Tiago Biachi de Castria, MD, PhD (PRINCIPAL_INVESTIGATOR) |
| Indiana University, Simon Comprehensive Cancer Center | Indianapolis | Indiana | 46202 | Anita Turk, M.D. (PRINCIPAL_INVESTIGATOR) |
| START Midwest | Grand Rapids | Michigan | 49546 | Sreenivasa R Chandana, M.D., Ph.D. (PRINCIPAL_INVESTIGATOR) |
| Washington University | St Louis | Missouri | 63110 | Kian-Huat Lim, M.D., Ph.D. (PRINCIPAL_INVESTIGATOR) |
| START New Jersey | East Brunswick | New Jersey | 08816 | Bruno S Fang, M.D. (PRINCIPAL_INVESTIGATOR) |
| Sarah Cannon Research Institute Oncology Partners | Nashville | Tennessee | 37203 | Meredith Pelster, MD (PRINCIPAL_INVESTIGATOR) |
| START Dallas Fort Worth | Fort Worth | Texas | 76104 | Salwan Al Mutar, M.D., M.Sc. (PRINCIPAL_INVESTIGATOR) |
| The University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | Christine Parseghian, MD (PRINCIPAL_INVESTIGATOR) |
| START Mountain Region | West Valley City | Utah | 84119 | José M Pacheco, M.D. (PRINCIPAL_INVESTIGATOR) |
| UVA Comprehensive Cancer Center | Charlottesville | Virginia | 22908 | Matthew Reilley, MD (PRINCIPAL_INVESTIGATOR) |
| Virginia Cancer Specialists | Fairfax | Virginia | 22031 | |
| Virginia Mason Medical Center | Seattle | Washington | 98101 | Jessica Lee, DO (PRINCIPAL_INVESTIGATOR) |
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