Back to Trials
NCT07644559PHASE2Recruiting

A Phase 2 Study of VS-7375 in Patients With KRAS G12D-Mutated Pancreatic Cancer

Verastem, Inc.

Start Date

6/16/2026

Completion Date

12/1/2028

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 Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * 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 Exclusion criteria: * 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 * Other protocol-defined inclusion/exclusion criteria may apply

Interventions

DRUG

VS-7375

DRUG

cetuximab

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Pancreatic Ductal Adenocarcinoma (PDAC)G12D Mutated KRAS

Locations

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