Back to Trials
NCT07020221PHASE1, PHASE2Recruiting

A Phase 1/2 Study of VS-7375 in Patients With KRAS G12D-Mutated Solid Tumors

Verastem, Inc.

Start Date

6/24/2025

Completion Date

12/1/2028

Summary

This study will assess the safety and efficacy of VS-7375 alone and in combination in patients with advanced solid tumors harboring a KRAS G12D-mutation.

Eligibility Criteria

Age Range: 18 years to No maximum

Key Inclusion Criteria: * Individuals ≥18 years of age. * Agreement to sign and date an informed consent form (ICF) approved by the Institutional Review Board (IRB)/Independent Ethics Committee (IEC). * Histologic or cytologic evidence of locally advanced unresectable or metastatic solid tumor harboring a KRAS G12D mutation. * Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. * Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 * Adequate organ function * Adequate cardiac function * Recovered from all AEs due to previous therapies to Grade ≤1 or baseline. * Agreement to use highly effective contraception Key Exclusion Criteria: * Underwent major surgical procedure as defined by the Investigator, other than for diagnosis, within 4 weeks prior to Cycle 1 Day 1, * Receipt of chemotherapy, targeted therapy, or radiotherapy (excluding palliative radiation) within 4 weeks or 5 half-lives, whichever is shorter, or immunotherapy within 4 weeks prior to Cycle 1 Day 1 * Treatment with any investigational drug at least 4 weeks or 5 half-lives, whichever is shorter, prior to Cycle 1 Day 1. * History of treatment with direct and specific KRAS G12D inhibitors. * Symptomatic, untreated, or actively progressing known central nervous system (CNS) metastases. * Inability to swallow oral medications. * Evidence or history of uncontrolled, clinically significant hematological, renal, hepatic, endocrine, pulmonary, gastrointestinal, cardiovascular, psychiatric, coagulation, neurologic, dermatologic, autoimmune, or allergic disease * Individuals who are pregnant or breastfeeding.

Interventions

DRUG

VS-7375

DRUG

Cetuximab

DRUG

Carboplatin + Pemetrexed + Pembrolizumab

DRUG

Gemcitabine

DRUG

Gemcitabine + Nab-paclitaxel

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 AdenocarcinomaNon Small Cell Lung CancerColorectal CancerSolid Tumor, AdultG12D Mutated KRAS

Locations

Cedars-Sinai Medical Center

Los Angeles, California 90048

United States

Johns Hopkins University

Baltimore, Maryland 21287

United States

Massachusetts General Hospital

Boston, Massachusetts 02114

United States

University of Michigan

Ann Arbor, Michigan 48109

United States

Washington University School of Medicine

St Louis, Missouri 63110

United States

Laura & Isaac Perlmutter Cancer Center at NYU Langone

New York, New York 10016

United States

Univ of Pennsylvania, Abramson Cancer Center

Philadelphia, Pennsylvania 19104

United States

SCRI Oncology Partners

Nashville, Tennessee 37203

United States

MD Anderson Cancer Center

Houston, Texas 77030

United States

Huntsman Cancer Institute

Salt Lake City, Utah 84112

United States

University of Virginia

Charlottesville, Virginia 22908

United States

Virginia Cancer Specialists

Fairfax, Virginia 22031

United States

Virginia Mason Medical Center

Seattle, Washington 98101

United States

Peninsula and Southeast Oncology

Frankston, Victoria 3199

Australia