Actively Recruiting

Phase 1
Phase 2
Age: 18Years +
All Genders
NCT07020221

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

Led by Verastem, Inc. · Updated on 2026-04-22

295

Participants Needed

14

Research Sites

179 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 18 years of age or older
  • Signed informed consent form approved by an ethics committee
  • Histologic or cytologic evidence of locally advanced unresectable or metastatic solid tumor with KRAS G12D mutation
  • Measurable disease based on RECIST v1.1 criteria
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Adequate organ and cardiac function
  • Recovery from all side effects of previous therapies to Grade 1 or baseline
  • Agreement to use highly effective contraception
Not Eligible

You will not qualify if you...

  • Major surgery within 4 weeks before starting treatment, except for diagnostic procedures
  • Chemotherapy, targeted therapy, or radiotherapy (except palliative radiation) within 4 weeks or 5 half-lives before treatment start
  • Immunotherapy within 4 weeks before treatment start
  • Participation in other investigational drug treatments within 4 weeks or 5 half-lives before treatment
  • Previous treatment with direct and specific KRAS G12D inhibitors
  • Symptomatic, untreated, or actively progressing central nervous system metastases
  • Inability to swallow oral medications
  • History or evidence of uncontrolled serious medical conditions including hematologic, renal, hepatic, endocrine, pulmonary, gastrointestinal, cardiovascular, psychiatric, coagulation, neurologic, dermatologic, autoimmune, or allergic diseases
  • Pregnancy or breastfeeding

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 14 locations

1

Cedars-Sinai Medical Center

Los Angeles, California, United States, 90048

Actively Recruiting

2

Johns Hopkins University

Baltimore, Maryland, United States, 21287

Actively Recruiting

3

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

Actively Recruiting

4

University of Michigan

Ann Arbor, Michigan, United States, 48109

Actively Recruiting

5

Washington University School of Medicine

St Louis, Missouri, United States, 63110

Actively Recruiting

6

Laura & Isaac Perlmutter Cancer Center at NYU Langone

New York, New York, United States, 10016

Actively Recruiting

7

Univ of Pennsylvania, Abramson Cancer Center

Philadelphia, Pennsylvania, United States, 19104

Actively Recruiting

8

SCRI Oncology Partners

Nashville, Tennessee, United States, 37203

Actively Recruiting

9

MD Anderson Cancer Center

Houston, Texas, United States, 77030

Actively Recruiting

10

Huntsman Cancer Institute

Salt Lake City, Utah, United States, 84112

Actively Recruiting

11

University of Virginia

Charlottesville, Virginia, United States, 22908

Actively Recruiting

12

Virginia Cancer Specialists

Fairfax, Virginia, United States, 22031

Actively Recruiting

13

Virginia Mason Medical Center

Seattle, Washington, United States, 98101

Actively Recruiting

14

Peninsula and Southeast Oncology

Frankston, Victoria, Australia, 3199

Actively Recruiting

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Research Team

V

Verastem Call Center

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

10

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