Trials / Recruiting
RecruitingNCT06487221
Avutometinib and Defactinib in Diffuse Gastric Cancer
A Phase II Trial of Avutometinib in Combination With Defactinib in Metastatic Diffuse Gastric Cancer
- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 27 (estimated)
- Sponsor
- Ryan H. Moy, MD, PhD · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
There are two main types of stomach cancer based on the appearance under the microscope: intestinal-type and diffuse-type. Some stomach cancers also have a mix of intestinal-type and diffuse-type (mixed type). The participants are being invited to take part in this research study due to having been diagnosed with stomach cancer that has spread to other parts of the body and/or cannot be surgically removed, has diffuse-type or mixed type cells or has gene changes that are associated with diffuse-type stomach cancers (such as mutations in the genes called CDH1 or RHOA), and have already been treated with chemotherapy and the disease is now growing. Defactinib is an oral drug that inhibits the protein focal adhesion kinase (FAK), which has been shown to promote growth of gastric cancer. Avutometinib (also known as VS-6766) is an oral drug that blocks an important signaling pathway in cancer cells known as the MAP kinase pathway. Avutometinib inhibits two proteins in the MAPK kinase pathway, RAF and MEK. The purpose of this study is to determine if the combination study treatment with defactinib and avutometinib is effective in improving the length of time after the start of treatment in which a participant is alive and their cancer does not grow or spread.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Avutometinib | 3.2mg orally |
| DRUG | Defactinib | 200 mg orally |
Timeline
- Start date
- 2024-10-28
- Primary completion
- 2028-11-30
- Completion
- 2029-05-30
- First posted
- 2024-07-05
- Last updated
- 2025-11-04
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06487221. Inclusion in this directory is not an endorsement.