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
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • VS-7375 — DRUG
    Taken by mouth
  • cetuximab — DRUG
    Intravenous infusion
  • panitumumab — DRUG
    Intravenous infusion
  • Cetuximab + mFOLFOX6 — DRUG
    Intravenous 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+ 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

Primary Outcome Measure

Confirmed ORR by blinded independent central review (BICR) per RESIST v1.1 - 2L CRC only [ Time Frame: 6 months ]

Central Contacts

Locations (8)

FacilityCityStateZIPSite coordinators
START Los AngelesLos AngelesCalifornia90025
START Hope Team
[email protected]
424-465-1820
Navid Hafez, M.D., MPH (PRINCIPAL_INVESTIGATOR)
Valkyrie Clinical Trials (contact for more locations)Los AngelesCalifornia90067
Trenis Palmer, PhD
[email protected]
912-398-3205
David Berz, MD, PhD, MPH (PRINCIPAL_INVESTIGATOR)
Moffitt Cancer CenterTampaFlorida33612
Cheyenne Schneider
[email protected]
813-745-3691
Tiago Biachi de Castria, MD, PhD (PRINCIPAL_INVESTIGATOR)
START MidwestGrand RapidsMichigan49546
START Hope Team
[email protected]
616-954-5554
Sreenivasa R Chandana, M.D., Ph.D. (PRINCIPAL_INVESTIGATOR)
START New JerseyEast BrunswickNew Jersey08816
START Hope Team
[email protected]
732-426-4750
Bruno S Fang, M.D. (PRINCIPAL_INVESTIGATOR)
START Dallas Fort WorthFort WorthTexas76104
START Hope Team
[email protected]
682-350-3010
Salwan Al Mutar, M.D., M.Sc. (PRINCIPAL_INVESTIGATOR)
START Mountain RegionWest Valley CityUtah84119
START Hope Team
[email protected]
801-907-4750
José M Pacheco, M.D. (PRINCIPAL_INVESTIGATOR)
UVA Comprehensive Cancer CenterCharlottesvilleVirginia22908
Clinical Trials Navigator
[email protected]
434-982-0539
Matthew Reilley, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Los Angeles, CA

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By condition
Colorectal cancer
By specialty
OncologyGI oncology
By research site
START Los Angeles· Los Angeles, CAValkyrie Clinical Trials (contact for more locations)· Los Angeles, CAMoffitt Cancer Center· Tampa, FLSTART Midwest· Grand Rapids, MISTART New Jersey· East Brunswick, NJSTART Dallas Fort Worth· Fort Worth, TX

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