Actively Recruiting
Avutometinib and Defactinib in Diffuse Gastric Cancer
Led by Ryan H. Moy, MD, PhD · Updated on 2025-11-04
27
Participants Needed
1
Research Sites
239 weeks
Total Duration
On this page
Sponsors
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Ryan H. Moy, MD, PhD
Lead Sponsor
V
Verastem, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of this study is to determine if the combination study treatment with avutometinib and defactinib will prolong life in participants, is effective in decreasing the size of the tumor(s), and if it is safe in subjects with diffuse-type stomach cancer.
CONDITIONS
Official Title
Avutometinib and Defactinib in Diffuse Gastric Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of gastric or gastroesophageal junction carcinoma classified as diffuse type, poorly cohesive, signet ring cell, or mixed type, or with CDH1 and/or RHOA mutations
- Prior treatment with at least one line of therapy for unresectable or metastatic disease including platinum and fluoropyrimidine
- ECOG performance status of 0 or 1
- Age 18 years or older
- Adequate organ function as defined by specific blood counts, liver, kidney, heart function, and coagulation parameters
- Disease that can be evaluated radiographically within 28 days prior to treatment
- Tumor accessible for fresh biopsy or malignant ascites suitable for paracentesis
- Baseline QTc interval less than 460 ms for females and 450 ms for males
- Recovery to grade 1 or better from prior treatment toxicities except for alopecia and stable peripheral neuropathy
- Agreement to use adequate contraception if of child-bearing potential
- Ability to understand and sign informed consent
You will not qualify if you...
- Systemic anti-cancer therapy within 3 weeks or 5 half-lives of prior drug
- Current use of other investigational agents
- History of other malignancies within 2 years except for certain low-risk cancers
- Major surgery within 4 weeks or radiotherapy within 1 week prior to treatment
- Treatment with warfarin unless switched to low-molecular-weight heparin
- Previous treatment with specific inhibitors of FAK, MEK, or KRAS
- Use of medications affecting metabolism of study drugs within 14 days
- Symptomatic brain metastases requiring steroids or interventions
- Active hepatitis B, hepatitis C, or HIV infection requiring therapy
- Active skin disorders requiring systemic therapy in the past year
- History of rhabdomyolysis
- Certain ocular disorders including glaucoma, retinal vein occlusion risk, or significant corneal disease
- Severe cardiac disease or congestive heart failure
- Inability to swallow oral medication
- Hypersensitivity to inactive ingredients of study drugs
- Pregnancy or breastfeeding
- Any other medical condition that poses high risk for toxicity as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Columbia University Irving Medical Center
New York, New York, United States, 10032
Actively Recruiting
Research Team
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Research Nurse Navigator
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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