RecruitingPhase 1Phase 2NCT07020221

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

A Phase 1/2, Open-label Study of VS-7375, a KRAS G12D (ON/OFF) Inhibitor, as Monotherapy and in Combination, in Patients With Advanced KRAS G12D-Mutated Solid Tumors

Sponsor

Verastem, Inc.

Enrollment

295 participants

Start Date

Jun 24, 2025

Study Type

INTERVENTIONAL

Conditions

Pancreatic Ductal Adenocarcinoma

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This early-phase study is testing a new targeted therapy called VS-7375 in people with advanced solid tumors that carry a specific genetic mutation called KRAS G12D — a mutation found in many pancreatic, lung, and colon cancers. **You may be eligible if...** - You are 18 or older - You have advanced cancer (unresectable or metastatic) confirmed to carry the KRAS G12D mutation - Your tumor has at least one measurable lesion - You are generally well (ECOG 0–1) - You have received at least one prior treatment and your cancer has progressed **You may NOT be eligible if...** - You recently had major surgery (other than for diagnosis) - You have active, uncontrolled brain metastases - You have significant heart, liver, or kidney problems - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGVS-7375

VS-7375 is a highly selective oral, non-covalent, small molecule KRAS G12D (ON/OFF) inhibitor.

DRUGCetuximab

Cetuximab is a monoclonal antibody targeting the epidermal growth factor receptor (EGFR).

DRUGCarboplatin + Pemetrexed + Pembrolizumab

A combination therapy regimen used as a first-line treatment for advanced non-squamous non-small cell lung cancer.

DRUGGemcitabine

A chemotherapy used for the treatment of several types of cancer including advanced or metastatic pancreatic ductal adenocarcinoma.

DRUGGemcitabine + Nab-paclitaxel

A chemotherapy regimen used for the treatment of advanced or metastatic pancreatic ductal adenocarcinoma.

Locations(14)

Cedars-Sinai Medical Center

Los Angeles, California, United States

Johns Hopkins University

Baltimore, Maryland, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

University of Michigan

Ann Arbor, Michigan, United States

Washington University School of Medicine

St Louis, Missouri, United States

Laura & Isaac Perlmutter Cancer Center at NYU Langone

New York, New York, United States

Univ of Pennsylvania, Abramson Cancer Center

Philadelphia, Pennsylvania, United States

SCRI Oncology Partners

Nashville, Tennessee, United States

MD Anderson Cancer Center

Houston, Texas, United States

Huntsman Cancer Institute

Salt Lake City, Utah, United States

University of Virginia

Charlottesville, Virginia, United States

Virginia Cancer Specialists

Fairfax, Virginia, United States

Virginia Mason Medical Center

Seattle, Washington, United States

Peninsula and Southeast Oncology

Frankston, Victoria, Australia

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07020221

Related Trials

Phase 1 Study to Investigate TCRTs KRAS Mutation in Unresectable, Advanced, and/or Metastatic Solid Tumors

NCT0621891418 locations

A Study Comparing BMS-986504 in Combination With Nab-paclitaxel and Gemcitabine Versus Placebo in Combination With Nab-paclitaxel and Gemcitabine in Participants With Untreated Metastatic Pancreatic Ductal Adenocarcinoma With Homozygous MTAP Deletion (MountainTAP-30)

NCT07076121279 locations

A Study to Assess IPN01194 When Administered Alone in Adults With Advanced Solid Tumours

NCT0630524712 locations

Lead-212 PSV359 Therapy for Patients With Solid Tumors

NCT067107567 locations

Phase I Study of [177Lu]Lu-DFC413 in Patients With Solid Tumors

NCT072616317 locations