Actively Recruiting
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
Led by Verastem, Inc. · Updated on 2026-04-22
295
Participants Needed
14
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of VS-7375, an oral drug that targets the KRAS G12D mutation, in patients with advanced solid tumors that have this specific mutation. The study includes patients with pancreatic ductal adenocarcinoma, non-small cell lung cancer, colorectal cancer, and other solid tumors harboring the KRAS G12D mutation. The trial is a Phase 1/2, open-label study sponsored by Verastem, Inc., aiming to find suitable doses and understand the drug's impact alone and in combination with other therapies. The study has several parts: dose escalation to find the best dose of VS-7375 alone and combined with cetuximab, carboplatin/pemetrexed/pembrolizumab, or gemcitabine-based therapies; and dose expansion to evaluate the effectiveness of these treatments at the recommended doses. Treatment cycles last 21 or 28 days, and combinations are tailored for different tumor types and patient groups, including older adults. Cetuximab is an antibody targeting EGFR, while other drugs used are chemotherapy or immunotherapy agents. Participants will have regular assessments to monitor safety, side effects, and how well the treatments work over up to 2.5 years. These include measuring disease response using standard criteria, monitoring adverse events, and evaluating drug levels in the body. The study tracks tolerability and side effects during treatment and continues follow-up after treatment ends. Participants must meet specific health and tumor criteria and agree to use contraception during the study.
CONDITIONS
Brief Title
A Phase 1/2 Study of VS-7375 in Patients With KRAS G12D-Mutated Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Individuals 18 years of age or older
- Signed informed consent approved by an ethics committee
- Histologic or cytologic confirmation 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
- Recovered from previous therapy adverse events to Grade 1 or baseline
- Agreement to use highly effective contraception
You will not qualify if you...
- Major surgery within 4 weeks before starting treatment, except for diagnostic procedures
- Chemotherapy, targeted therapy, or radiotherapy (excluding palliative radiation) within 4 weeks or 5 half-lives before treatment start
- Immunotherapy within 4 weeks before treatment start
- Treatment with investigational drugs within 4 weeks or 5 half-lives before treatment start
- Previous treatment with direct, specific KRAS G12D inhibitors
- Symptomatic, untreated, or actively progressing central nervous system metastases
- Inability to swallow oral medications
- Uncontrolled or significant hematological, 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2.5 years
Participants receive initial dose escalation to determine the recommended phase 2 dose (RP2D) of VS-7375 alone or in combination with other drugs.
Repeated visits in 21-day treatment cycles during dose escalation
Duration - Up to 2.5 years
Participants receive VS-7375 as monotherapy or in combination with cetuximab, carboplatin/pemetrexed/pembrolizumab, gemcitabine, or gemcitabine/nab-paclitaxel at the recommended phase 2 dose to evaluate efficacy and safety.
Repeated visits in 21- or 28-day treatment cycles during treatment
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
Research Team
V
Verastem Call Center
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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