Actively Recruiting
A Phase II Trial of Avutometinib in Combination With Defactinib in Metastatic Diffuse Gastric Cancer
Led by Ryan H. Moy, MD, PhD · Updated on 2025-11-04
27
Participants Needed
1
Research Sites
25 weeks
Total Duration
On this page
Sponsors
R
Ryan H. Moy, MD, PhD
Lead Sponsor
V
Verastem, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to evaluate the combination of two oral drugs, avutometinib and defactinib, in people with diffuse-type or mixed-type stomach cancer that has spread or cannot be surgically removed. The study focuses on participants whose cancer has gene changes related to diffuse-type stomach cancers, such as mutations in CDH1 or RHOA, and whose disease is growing despite prior chemotherapy. The goal is to see if this treatment can safely extend life and reduce tumor size. Participants will take avutometinib at a dose of 3.2 mg by mouth twice weekly for three weeks, followed by one week off. They will also take defactinib 200 mg orally twice daily for three weeks, followed by one week without treatment. This cycle will continue as part of the study treatment. The trial does not include a placebo group and is open label, meaning both doctor and participant know the treatments given. During the study, participants will have regular evaluations including radiographic scans to measure tumor status, laboratory tests to check organ function, and monitoring of side effects. The main measure of success is progression-free survival at six months, with other outcomes including tumor response and overall survival tracked up to five years. Participants will be closely followed throughout the treatment period and beyond to assess safety and effectiveness.
CONDITIONS
Brief Title
Avutometinib and Defactinib in Diffuse Gastric Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologic or cytologic confirmation of diffuse type, poorly cohesive, signet ring cell, or mixed gastric/gastroesophageal junction cancer, or known CDH1/RHOA mutations
- Prior treatment with at least one chemotherapy regimen for unresectable or metastatic disease including platinum and fluoropyrimidine
- ECOG performance status of 0 or 1
- Age 18 years or older
- Adequate organ function shown by specific lab tests
- Disease measurable or evaluable by radiographic studies within 28 days before starting treatment
- Tumor accessible for fresh biopsy
- Baseline QTc interval under specified limits
- Recovery from prior treatment toxicities to at least Grade 1 except certain exceptions
- Agreement to use effective contraception if applicable
- Ability to understand and sign informed consent
You will not qualify if you...
- Use of systemic anti-cancer therapy within 3 weeks or 5 half-lives before starting study treatment
- Current participation in other investigational drug studies
- History of other malignancies within 2 years except low-risk cancers
- Major surgery within 4 weeks or palliative radiotherapy within 1 week before treatment
- Use of warfarin unless switched to low-molecular-weight heparin
- Prior treatment with specific inhibitors of FAK, MEK, or KRAS
- Use of drugs or substances with strong interactions with study drugs within 14 days before treatment
- Symptomatic brain metastases requiring steroids or interventions
- Active viral infections like hepatitis B/C or HIV requiring treatment
- Active skin disorders treated systemically in the past year
- History of rhabdomyolysis
- Certain eye disorders or conditions increasing risk for retinal problems
- Significant heart failure or recent serious cardiac events
- Inability to swallow oral medications
- Known allergy to ingredients in study drugs
- Pregnancy or breastfeeding
- Other medical conditions placing participant at high risk as judged by investigator
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 - Repeated 3-week cycles followed by 1 week of rest, continued until disease progression or unacceptable side effects.
Participants receive oral study drugs Avutometinib and Defactinib in cycles with treatment followed by rest periods.
Weekly visits for treatment monitoring
Trial Site Locations
Total: 1 location
1
Columbia University Irving Medical Center
New York, New York, United States, 10032
Actively Recruiting
Research Team
R
Research Nurse Navigator
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here